Tensioning apparatus for hemostasis and maintaining catheter placement

ABSTRACT

Disclosed herein are improved methods and apparatuses for providing hemostasis within a cavity defined by an internal surface of a bleeding tissue space. A catheter comprising a proximal end and a distal end may be advanced into the cavity through a proximal opening of the tissue space into the cavity. A distal balloon coupled to the catheter may be expanded, and the catheter tensioned to apply pressure to the internal surface of the tissue space to inhibit bleeding of the tissue space.

CROSS-REFERENCE

The present application is a continuation of U.S. application Ser. No.15/976,650, filed May 10, 2018, which is a continuation of InternationalApplication No. PCT/US17/23062, filed Mar. 17, 2017, which claims thebenefit of U.S. Provisional Application No. 62/380,321, filed Aug. 26,2016, U.S. Provisional Application No. 62/324,831, filed Apr. 19, 2016,and U.S. Provisional Application No. 62/310,614, filed Mar. 18, 2016,the entire disclosures of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

Prior methods and systems for achieving hemostasis following a minimallyinvasive tissue removal procedure can be less than ideal in at leastsome respects. Prior methods and systems frequently use thermal means tostop the bleeding, such as cauterization of one or more sites within thetissue. For example, following resection of the prostate in thetreatment of prostate cancer or benign prostate hyperplasia,prophylactic cauterization may be applied around the neck of the bladderto reduce bleeding. Thermal means of hemostasis can damage thesurrounding parenchymal tissue when used to reduce bleeding. Therefore asafer means of hemostasis is desired following tissue resection.

Prior methods and systems frequently employ a Foley or indwellingcatheter following a tissue removal procedure. The Foley catheter canallow for irrigation of the tissue volume to prevent clot buildup, andthe color of the fluid outflow from the tissue volume can be monitoredto determine the extent of bleeding and/or identify whether the bleedinghas stopped. Such a procedure often requires a patient to stay at thehospital for an extended period of time for monitoring until hemostasisis achieved, frequently necessitating an overnight stay following thetissue removal procedure, and thus resulting in additional expenses aswell as inconvenience for the patient.

In light of the above, it would be desirable to provide improved systemsand methods for achieving hemostasis in a tissue volume following aminimally invasive tissue removal procedure. In particular, it would bedesirable to provide improved systems and methods that can achievehemostasis in a safe and effective manner while shortening the amount oftime required to achieve hemostasis, such that the entire the tissueremoval procedure can be performed as an outpatient procedure.

SUMMARY OF THE INVENTION

The present disclosure describes minimally invasive systems, apparatus,and methods for providing hemostasis within a tissue cavity defined byan internal surface of a bleeding tissue volume. The disclosed systems,apparatus, and methods are suitable for providing a hemostatic agent toa tissue volume having a proximal opening and a distal opening, withoutoccluding the proximal opening, the distal opening, and a path extendingbetween the proximal and distal openings with the hemostatic agent. Theembodiments disclosed herein are particularly advantageous in achievinghemostasis within a closed tissue volume, such as a volume of an organdisposed between two or more organs, wherein maintaining fluidcommunication between the organs is helpful for the proper functioningof the organs. For example, the tissue volume may comprise a prostaticcapsule of a prostate, the prostate having a proximal opening to theurethra and a distal opening to the bladder, wherein it is helpful tomaintain a clear pathway from the bladder through the prostate to theurethra.

In one aspect, a method of providing treatment to a tissue enclosing aspace, such as providing hemostasis, comprises advancing a catheter intothe space enclosed within the tissue, and applying a treatment agent,for example a hemostatic agent or a sealant, from the catheter to thespace enclosed with the tissue to inhibit bleeding from the tissue intothe space. The treatment agent may be applied from a delivery portpositioned proximally of a distal end of the advanced catheter. Themethod may further comprise positioning a distal expandable support,such as a distal balloon, coupled to the catheter adjacent a distalopening of the tissue to the space and expanding the distal expandablesupport to seal the distal opening. The method may further comprisepositioning a proximal expandable support, such as a proximal balloon,coupled to the catheter at least partially within the space. The methodmay further comprise expanding the proximal expandable support tocompress the sealant against the internal surface of the tissue. Themethod may further comprise positioning the proximal expandable supportadjacent a proximal opening of the tissue to the space and expanding theproximal expandable support to seal the proximal opening. The method mayfurther comprise moving the expanded proximal expandable support along alongitudinal axis of the catheter between the proximal opening and thedistal opening to spread the sealant over the internal surface of thetissue space. The method may further comprise removing excess treatmentagent from the space through an overflow port of the catheter. Themethod may further comprise aspirating resected tissue and fluids fromthe space through an aspiration port of the catheter and insufflatingthe space to the predetermined profile.

The hemostatic agent may be applied to an internal surface of the tissuewithout occluding a proximal opening of the tissue to the space, thedistal opening of the tissue, and a path extending therebetween with thetreatment agent.

The distal expandable support may comprise a plurality of pores suchthat applying the treatment agent comprises expanding the distalexpandable support with the treatment agent and delivering the treatmentagent from the distal expandable support through the plurality of poresinto the space between the expanded distal expandable support and aninternal surface of the tissue.

Applying the treatment agent from the catheter may comprise deliveringthe treatment agent from the catheter into the space. Delivering thetreatment agent may comprise delivering the treatment agent into thespace between the internal surface of the tissue and the proximalballoon in an unexpanded configuration, and expanding the proximalexpandable support to compress the treatment agent against the internalsurface of the tissue. The proximal expandable support may comprise aplurality of pores such that delivering the treatment agent comprisesexpanding the proximal expandable support with the treatment agent anddelivering the treatment agent from the proximal expandable supportthrough the plurality of pores into the space between the expandedproximal expandable support and the internal surface of the tissuespace. Delivering the treatment agent may comprise delivering thetreatment agent into the space between the sealed distal opening and thesealed proximal opening.

Applying the treatment agent may comprise providing a scaffold withinthe space, and compressing the scaffold against an internal surface ofthe tissue. The scaffold may be disposed over at least a portion of anexternal surface of the proximal expandable support such thatcompressing the scaffold comprises expanding the proximal expandablesupport to expand the scaffold, thereby compressing the scaffold againstthe internal surface of the tissue. The scaffold may be further disposedover at least a portion of an external surface of the distal expandablesupport such that expanding the distal expandable support expands thescaffold to compress the scaffold against the internal surface of thetissue near the distal opening.

Alternatively or in combination, applying the treatment agent maycomprise expanding the proximal expandable support within the space in amanner so as to cause a sheath covering the treatment agent to retractor detach from the treatment agent, exposing the treatment agent to thetissue.

The proximal expandable support and the distal expandable support may becontinuous with one another and may together comprise a singleexpandable support assembly having an expandable proximal portion and anexpandable distal portion. One or more of the proximal or distalexpandable support may be expanded to one or more of a spherical,toroidal, cylindrical, conical, dual cone, irregular, or dumbbell shape.One or more of the proximal or the distal expandable support maycomprise a proximal or distal inflatable balloon, respectively, and theone or more of the proximal or distal expandable support may be expandedby inflating the one or more of the proximal or distal inflatableballoon, such as to a fully expanded configuration.

The catheter may comprise a delivery probe configured to deliver energyto a predetermined profile of the tissue space. Applying the treatmentagent may comprise delivering a treatment agent from the delivery probeto the predetermined profile of the tissue space. Energy may bedelivered from the delivery probe to the tissue at a first flow rate toresect the tissue and thereby create the tissue space having thepredetermined profile, wherein delivering the treatment agent comprisesdelivering the treatment agent at a second flow rate lower than thefirst flow rate. Resected tissue and fluids may be aspirated from thespace through an aspiration port of the catheter, and the space may beinsufflated to the predetermined profile.

The tissue may comprise a prostatic capsule of a prostate, wherein theproximal opening comprises an opening to a urethra and the distalopening comprises a bladder neck between the prostate and a bladder.Positioning the distal expandable support may comprise positioning thedistal expandable support within the bladder adjacent the bladder neck.Expanding the distal expandable support may comprise sealing the bladderneck.

One or more of the proximal or distal expandable members may be expandedto apply a pressure against the tissue. The pressure applied may begreater than a blood pressure of the subject so as to promotehemostasis. The blood pressure of the subject may be measured and thepressure to which the one or more of the proximal or distal members areexpanded to may be based on the measured pressure.

A location of the catheter may be determined in response to a visual ortactile inspection of one or more indicia positioned on an outer surfaceof a proximal portion of the catheter advanced into the space.

One or more of the distal or the proximal expandable supports may bevisualized such as with ultrasound. One or more radiopaque markerscoupled to the one or more of the proximal or distal expandable supportsmay be visualized.

The tissue may comprise a prostatic capsule of a prostate, and theproximal expandable support may be expanded within the space in a mannerto reduce contact between the expanded proximal expandable support in afully expanded configuration and a verumontanum of the prostate. Theexpanded proximal expandable support in the fully expanded configurationmay comprise a concavity in a region near the verumontanum of theprostate, and one or more of the catheter or the proximal expandablesupport may comprise a user-perceptible indicia for the concavity.

In another aspect, an apparatus for providing treatment to a tissueenclosing a space, such as providing hemostasis, comprises a catheterhaving a distal end and a proximal end and configured to be advancedinto the space enclosed with the tissue through an opening into theenclosed space. The catheter comprises a treatment agent infusion portnear the proximal end, and a treatment agent delivery port of thecatheter coupled to the treatment agent infusion port. The treatmentagent delivery port is configured to deliver a treatment agentintroduced into the catheter through the treatment agent infusion portto the space such as to inhibit bleeding of the tissue.

The apparatus may further comprise a distal expandable support adjacentthe distal end of the catheter, the distal expandable support maycomprise a distal inflatable balloon fluidly coupled to the distalinflation port. The apparatus may be configured to prevent the treatmentagent from occluding the opening into the space. The distal expandablesupport may comprise a plurality of pores, wherein the treatment agentinfusion port and the distal inflation port are the same port, andwherein the expandable support introduced into the catheter is deliveredto the distal expandable support to expand the distal expandable supportand to subsequently enter the space through the plurality of pores ofthe distal expandable support. The distal expandable support may beconfigured to have one or more of a spherical, toroidal, cylindrical,conical, dual cone, irregular, or dumbbell shape when expanded.

The catheter may further comprise a proximal inflation port at theproximal end, and the apparatus may further comprise a proximalexpandable support which may comprise a proximal inflatable balloonpositioned proximally with respect to the distal expandable support. Theproximal expandable support may be configured to be expanded within thespace to compress the treatment agent delivered to the space against aninternal surface of the tissue. The proximal expandable support maycomprise a plurality of pores, wherein the treatment agent infusion portand the proximal inflation port are the same port. The treatment agentintroduced into the catheter may be delivered to the proximal expandablesupport to expand the proximal expandable support and to subsequentlyenter the space through the plurality of pores of the proximalexpandable support. The proximal expandable support may be configured tobe expanded near a proximal opening of the tissue to seal the proximalopening, and the sealant delivery port may be positioned distally withrespect to the proximal expandable support to deliver the sealant in thespace between the sealed distal opening and the sealed proximal opening.The apparatus may further comprise an actuation mechanism coupled to theproximal expandable support, the actuation mechanism configured to movethe proximal expandable support, in an expanded configuration, along alongitudinal axis of the catheter between the proximal opening and thedistal opening to spread the sealant over the internal surface of thetissue. The proximal expandable support may be configured to have one ormore of a spherical, toroidal, cylindrical, conical, dual cone,irregular, or dumbbell shape when expanded.

The catheter may further comprise a sealant overflow port distallyadjacent the sealant delivery port, the sealant overflow port configuredto remove excess sealant from the space.

The tissue may comprise a prostatic capsule of a prostate, and whereinthe proximal expandable support has a fully expanded shape configured toreduce contact with a verumontanum of the prostate. The proximalexpandable support may further comprise a user-perceptible indicia forthe concavity. The proximal expandable support may have a non-uniformthickness, which may be configured to provide the proximal balloon witha predetermined shape.

The tissue may comprise a prostatic capsule of a prostate, the proximalopening may comprise an opening to a urethra, and the distal opening maycomprise a bladder neck between the prostate and a bladder. The distalballoon may be sized and shaped to be advanced into the bladder andengage the bladder neck when expanded.

At least a portion of an outer surface of the distal expandable supportmay be textured. The distal expandable support may comprise one or moreof an ultrasound hyperechoic material or a radiopaque marker to aidvisualization. The distal expandable support may have a non-uniformthickness. The non-uniform thickness of the distal expandable supportmay be configured to provide the distal expandable support with apredetermined shape. The distal expandable support may comprise one ormore of a compliant material or a non-compliant material. At least aportion of the distal expandable support may be coated with a hemostaticagent.

The proximal expandable support may comprise one or more of a compliantmaterial or a non-compliant material. At least a portion of the proximalexpandable support may be coated with a treatment agent.

The catheter may further comprise a treatment agent overflow portdistally adjacent the treatment agent delivery port, the treatment agentoverflow port configured to remove excess treatment agent from thespace.

The apparatus may further comprise a sheath positioned over a region ofthe catheter adjacent the treatment agent port and coupled to the distalballoon, wherein expansion of the distal expandable support may causethe sheath to retract or detach from the region to expose the treatmentagent port.

The catheter may comprise one or more indicia disposed on an outersurface of a proximal portion thereof, the one or more indicia may beconfigured to be visually or tactilely inspected to determine a locationof the catheter relative to the tissue. The one or more indicia maycomprise a plurality of bands positioned on the outer surface of theproximal portion of the catheter.

In another aspect, an apparatus for providing hemostasis to a tissueenclosing a space comprises a catheter having a distal end and aproximal end, the catheter comprising a distal balloon inflation portand a proximal balloon inflation port at the proximal end. The apparatusfurther comprises a distal balloon adjacent the distal end of thecatheter, the distal balloon fluidly coupled to the distal ballooninflation port. The apparatus further comprises a proximal balloonproximally adjacent the distal balloon, the proximal balloon fluidlycoupled to the proximal balloon inflation port. The apparatus furthercomprises a sealant scaffold disposed over at least a portion of anexternal surface of the proximal balloon. The catheter is configured tobe advanced into the space through a proximal opening of the tissue, thedistal balloon is configured to be expanded near a distal opening of thetissue to seal the distal opening, and the proximal balloon isconfigured to be expanded with the space thereby expanding andcompressing the sealant scaffold against an internal surface of thetissue.

The sealant scaffold may be further disposed over at least a portion ofan external surface of the distal balloon, and wherein expanding thedistal balloon may expand the sealant scaffold to compress the sealantscaffold against the internal surface of the tissue space near thedistal opening.

In another aspect, an apparatus for providing hemostasis to a tissueenclosing a space comprises a delivery probe having a proximal end and adistal end, the delivery probe configured to be advanced into the spacethrough a proximal opening of the tissue. The delivery probe comprisesan opening near the distal end to deliver a sealant through the proximalopening. The apparatus further comprises a processor operably coupled tothe delivery probe and configured to control delivery of the sealantfrom the delivery probe to deliver the sealant to a predeterminedprofile of the tissue space. The apparatus may be configured to preventthe sealant from occluding the proximal opening.

The apparatus may further comprise a distal balloon adjacent the distalend of the delivery probe and a distal balloon inflation port at theproximal end of the delivery probe, wherein the distal balloon may beconfigured to be expanded near a distal opening of the tissue to sealthe distal opening. The delivery probe may further comprise anaspiration port near the distal end, the aspiration port configured toremove resected tissue and fluids from the cavity. The delivery probemay further comprise an insufflation port near the distal end, theinsufflation port configured to insufflate the cavity to thepredetermined profile.

In another aspect, a method of providing hemostasis to a tissueenclosing a space comprises advancing a catheter into the space througha proximal opening of the tissue, wherein the tissue has the proximalopening and a distal opening to the space. The method further comprisesapplying a hemostatic agent from the catheter to an internal surface ofthe tissue to inhibit bleeding of the tissue, without occluding theproximal opening, the distal opening, and a path extending therebetweenwith the hemostatic agent.

In another aspect, a method of providing hemostasis within a prostaticcapsule of a prostate is provided. A catheter may be advanced into theprostatic capsule through a proximal opening of the prostatic capsule.An expandable support coupled to the catheter may be positioned adjacenta distal opening of the prostatic capsule. The expandable support may beexpanded to seal the distal opening. A hemostatic agent may be appliedfrom the catheter to the internal surface of the prostatic capsule toinhibit bleeding. The hemostatic agent may be applied to the internalsurface of the prostatic capsule without occluding the proximal opening,the distal opening, and a path extending therebetween with thehemostatic agent.

To apply the hemostatic agent, a sealant may be delivered from thecatheter into the prostatic capsule. The sealant may be deliveredthrough a delivery port disposed near the expandable support. Thesealant may be delivered into the prostatic capsule between the internalsurface of the prostatic capsule and the expandable support in anunexpanded configuration. The expandable support may be expanded tocompress the sealant against the internal surface of the prostaticcapsule. Excess sealant may be removed from the cavity through a sealantoverflow port of the catheter.

The expandable support may comprise a plurality of pores. To deliver thesealant, the expandable support with the sealant may be expanded and thesealant may be delivered from the expandable support through theplurality of pores into the prostatic capsule between the expandedexpandable support and the internal surface of the prostatic capsule.

To apply the hemostatic agent, a sealant scaffold may be provided withinthe prostatic capsule, and the sealant scaffold may be compressedagainst the internal surface of the prostatic capsule. The sealantscaffold may be disposed over at least a portion of an external surfaceof the expandable support. To compress the sealant scaffold, theexpandable support may be expanded to expand the sealant scaffold,thereby compressing the sealant scaffold against the internal surface ofthe prostatic capsule.

The catheter may comprise a delivery probe configured to deliver energyto a predetermined profile of the tissue space, and to apply thehemostatic agent, a sealant may be delivered from the delivery probe tothe predetermined profile of the tissue space. Energy may be deliveredfrom the delivery probe to the tissue space at a first flow rate toresect the tissue space and thereby create the cavity having thepredetermined profile. The sealant may be delivered at a second flowrate lower than the first flow rate. Resected tissue and fluids may beaspirated from the cavity through an aspiration port of the catheter,and the cavity may be insufflated to the predetermined profile.

The proximal opening may comprise an opening to a urethra and the distalopening comprises a bladder neck between the prostate and a bladder. Thedistal balloon may be positioned within the bladder adjacent the bladderneck, and the distal balloon may be expanded to seal the bladder neck.

The expandable support may be expanded to a pressure greater than ablood pressure of a subject. The target pressure may be determined inresponse to a blood pressure of a patient, which may be determined ormeasured.

The expandable support may be visualized, such as with ultrasound. Oneor more radiopaque markers coupled to the expandable support may bevisualized to visualize the expandable support.

The expandable support may be expanded to one or more of a spherical,toroidal, cylindrical, conical, dual cone, irregular, or dumbbell shape.

The expandable support may be expanded in a manner to reduce contactbetween the expanded expandable support in a fully expandedconfiguration and a verumontanum of the prostate. The expandedexpandable support in the fully expanded configuration may comprise aconcavity in a region near the verumontanum of the prostate. One or moreof the catheter or the expandable support may comprise auser-perceptible indicia for the concavity.

The hemostatic agent may be covered by a sheath, and expanding theexpandable support may cause the sheath to retract or detach from thehemostatic agent, exposing the hemostatic agent.

The expandable support may comprise an inflatable balloon and theexpandable support may be expanded by inflating the inflatable balloon.

The expandable support may comprise a distal expandable support, and aproximal expandable support coupled to the catheter may be positioned atleast partially within the prostatic cavity. The hemostatic agent may bedelivered into the prostatic capsule between the internal surface of theprostatic capsule and the proximal expandable support in an unexpandedconfiguration. The proximal expandable support may be expanded tocompress the sealant against the internal surface of the prostaticcapsule. The proximal expandable support may be positioned adjacent theproximal opening and the proximal expandable support may be expanded toseal the proximal opening. The sealant may be delivered into the cavitybetween the sealed distal opening and the sealed proximal opening. Theproximal expandable support may be expanded and moved along alongitudinal axis of the catheter between the proximal opening and thedistal opening to spread the sealant over the internal surface of theprostatic capsule. The proximal expandable support may comprise aproximal inflatable balloon, and the proximal expandable support may beexpanded by inflating the proximal inflatable balloon. The expandablesupport may comprise the proximal expandable support and the distalexpandable support, the distal expandable support may comprise a distalballoon in fluid communication with the proximal balloon, inflating theproximal inflatable balloon may also inflate the distal inflatableballoon.

A location of the catheter may be determined in response to a visual ortactile inspection of one or more indicia positioned on an outer surfaceof a proximal portion of the catheter advanced into the space. The oneor more indicia may comprise a plurality of bands positioned on theouter surface of the proximal portion of the catheter.

In another aspect, an apparatus for providing hemostasis within a cavitydefined by an internal surface of a bleeding tissue space is provided.The apparatus may comprise a catheter having a distal end and a proximalend, a balloon adjacent the distal end of the catheter, and a sealantdelivery port of the catheter proximally adjacent to the balloon. Thecatheter may comprise a distal balloon inflation port near the distalend and a sealant infusion port at the proximal end. The balloon may befluidly coupled to the distal balloon inflation port. The sealantdelivery port may be fluidly coupled to the sealant infusion port. Thecatheter may be configured to be advanced into the cavity through aproximal opening of the tissue space. The balloon may be configured tobe expanded near a distal opening of the tissue space to reversibly sealthe distal opening. The sealant delivery port may be configured todeliver a sealant introduced into the catheter through the sealantinfusion port to the cavity to inhibit bleeding of the tissue space.

The apparatus may be configured to prevent the sealant from occludingthe distal opening, the proximal opening, and a path extendingtherebetween.

The balloon may comprise a distal balloon. The catheter may furthercomprise a proximal balloon inflation port at the proximal end. Theapparatus may further comprise a proximal balloon positioned proximallywith respect to the distal balloon. The proximal balloon may beconfigured to be expanded within the cavity to compress the sealantdelivered to the cavity against the internal surface of the tissuespace. The proximal balloon may comprise a plurality of pores, thesealant infusion port and the proximal balloon inflation port may be thesame port, and the sealant introduced into the catheter may be deliveredto the proximal balloon to expand the proximal balloon and tosubsequently enter the cavity through the plurality of pores of theproximal balloon. The proximal balloon may be configured to be expandednear a proximal opening of the tissue space to seal the proximalopening, and the sealant delivery port may be positioned distally withrespect to the proximal balloon to deliver the sealant in the cavitybetween the sealed distal opening and the sealed proximal opening.

The apparatus may further comprise an actuation mechanism coupled to theproximal balloon. The actuation mechanism may be configured to move theproximal balloon, in an expanded configuration, along a longitudinalaxis of the catheter between the proximal opening and the distal openingto spread the sealant over the internal surface of the tissue space.

The catheter may further comprise a sealant overflow port distallyadjacent the sealant delivery port. The sealant overflow port may beconfigured to remove excess sealant from the cavity.

The tissue space may comprise a prostatic capsule of a prostate. Theproximal opening may comprise an opening to a urethra, the distalopening may comprise a bladder neck between the prostate and a bladder,and the distal balloon may be sized and shaped to be advanced into thebladder and engage the bladder neck when expanded.

In another aspect, an apparatus for providing hemostasis within a cavitydefined by an internal surface of a bleeding tissue space is provided.The apparatus may comprise a catheter having a distal end and a proximalend, a distal balloon adjacent the distal end of the catheter, aproximal balloon proximally adjacent the distal balloon, and a sealantscaffold disposed over at least a portion of an external surface of theproximal balloon. The catheter may comprise a distal balloon inflationport near the distal end and a proximal balloon inflation port near theproximal end. The distal balloon may be fluidly coupled to the distalballoon inflation port. The proximal balloon may be fluidly coupled tothe proximal balloon inflation port. The catheter may be configured tobe advanced into the cavity through a proximal opening of the tissuespace. The distal balloon may be configured to be expanded near a distalopening of the tissue space to seal the distal opening. The proximalballoon may be configured to be expanded with the cavity therebyexpanding and compressing the sealant scaffold against the internalsurface of the tissue space. The sealant scaffold may be furtherdisposed over at least a portion of an external surface of the distalballoon. Expanding the distal balloon may expand the sealant scaffold tocompress the sealant scaffold against the internal surface of the tissuespace near the distal opening.

In another aspect, an apparatus for providing hemostasis non-invasivelywithin a cavity defined by an internal surface of a bleeding tissuespace is provided. The apparatus may comprise a delivery probe having aproximal end and a distal end. The delivery probe may be configured tobe advanced into the cavity through a proximal opening of the tissuespace, and may comprise an opening near the distal end to deliver asealant through the opening into the cavity. The apparatus may furthercomprise a processor operably coupled to the delivery probe andconfigured to control delivery of the sealant from the delivery probe todeliver the sealant to a predetermined profile of the tissue space.

The apparatus may be configured to prevent the sealant from occludingthe distal opening, the proximal opening, and a path extendingtherebetween.

The apparatus may further comprise a distal balloon adjacent the distalend of the delivery probe and a distal balloon inflation port at theproximal end of the delivery probe. The distal balloon may be configuredto be expanded near a distal opening of the tissue space to seal thedistal opening.

The delivery probe may further comprise an aspiration port near thedistal end. The aspiration port may be configured to remove resectedtissue and fluids from the cavity. The delivery probe may furthercomprise an insufflation port near the distal end, the insufflation portconfigured to insufflate the cavity to the predetermined profile.

In another aspect, a method of providing hemostasis to a tissueenclosing a space is provided. The tissue may have a proximal openingand a distal opening to the space. A catheter may be advanced into thespace through the proximal opening of the tissue. A hemostatic agent maybe applied from the catheter to an internal surface of the tissue toinhibit bleeding of the tissue, without occluding the proximal opening,the distal opening, and a path extending therebetween with thehemostatic agent.

In another aspect, an apparatus for providing hemostasis to a tissueenclosing a space is provided. The apparatus may comprise a catheterhaving a distal end and a proximal end, a catheter balloon inflationport near the proximal end, a balloon fluidly coupled to the ballooninflation port, and a sealant and a therapeutic agent supported with theballoon. The catheter may be configured to be advanced into the spacethrough a proximal opening of the tissue. The balloon may be configuredto be expanded within the space thereby expanding and urging the sealantagainst an internal surface of the tissue.

In another aspect, an apparatus for providing hemostasis to a tissueenclosing a space is provided. The apparatus may comprise a catheterhaving a distal end and a proximal end, a catheter balloon inflationport near the proximal end, an expandable member coupled to the distalend of the catheter, and a sealant and a therapeutic agent supportedwith the expandable member. The catheter may be configured to beadvanced into the space through a proximal opening of the tissue. Theexpandable member may be configured to be expanded within the spacethereby expanding and urging the sealant against an internal surface ofthe tissue. The expandable member may comprise one or more of aself-expanding nitinol stent, a polymer-based stent, a dissolvablestent, one or more staples, one or more sutures, one or more barbs, orany combination thereof.

In another aspect, a method of providing hemostasis to a tissueenclosing a space of a subject is provided. A catheter may be appliedinto the space enclosed within the tissue. An expandable support coupledto the catheter may be positioned adjacent a distal opening of thetissue to the space. The expandable support may be expanded to a balloonpressure greater than a blood pressure of the subject, thereby applyingcompression to the tissue with the expandable support. The balloonpressure may be determined in response to a blood pressure of thesubject, which may be determined or measured.

The expandable support may be visualized, such as with ultrasound. Oneor more radiopaque markers coupled to the expandable support may bevisualized to visualize the expandable support.

The expandable support may be expanded to one or more of a spherical,toroidal, cylindrical, conical, dual cone, irregular, or dumbbell shape.

The expandable support may comprise an inflatable balloon, and theexpandable support may be expanded by inflating the inflatable balloon.

The tissue may comprise a prostatic capsule of a prostate, and whereinthe expandable support may be expanded in a way to reduce contactbetween the expanded expandable support in a fully expandedconfiguration and a verumontanum of the prostate. The expandedexpandable support in the fully expanded configuration may comprise aconcavity in a region near the verumontanum of the prostate. One or moreof the catheter or the expandable support may comprise auser-perceptible indicia for the concavity.

When the expandable support is expanded to seal the opening, theexpanded expandable support may conform to a shape of the space.

A size of the expandable support may be selected in response to a volumeof the space prior to applying the catheter and positioning theexpandable support.

The tissue may comprise a prostatic capsule of a prostate, the proximalopening may comprise an opening to a urethra, and the distal opening maycomprise a bladder neck between the prostate and a bladder. Theexpandable support may be positioned within the bladder adjacent thebladder neck, and the expandable support may be expanded to seal thebladder neck. The expandable support may be expanded to an expandedconfiguration at least partially filling the prostatic capsule andextruding into the bladder. The expandable support may comprise a rigidbladder portion for extruding into the bladder.

The expandable support may comprise a distal expandable support. Aproximal expandable support coupled to the catheter may be positionedadjacent the distal opening of the tissue to the space. The proximalexpandable support may be expanded to apply compression to the tissue inthe space. The proximal expandable support may be made of one or more ofa compliant material or a non-compliant material.

The expandable support may be expanded by pressing a mesh disposed overthe expandable support against the tissue. The expandable support mayfurther be collapsed, retracting the collapsed expandable support andthe catheter from the space, and leaving the mesh in the space. The meshmay be at least partially bioabsorbable or resorbable. The mesh may becoated with a clot promoting agent. The clot promoting agent maycomprise one or more of fibrin or thrombin.

When the expandable support is expanded, a scaffold disposed over theexpandable support may be pressed against the tissue. The scaffold maycomprise a silicone shaped stent. The expandable support may further becollapsed, retracting the collapsed expandable support and the catheterfrom the space, and leaving the scaffold in the space. The scaffold maybe removed from the space after a time delay such as between about 1 to3 days.

The balloon may be coated with a hemostatic agent.

The expandable support may comprise a plurality of pores, and atherapeutic agent may be delivered from the balloon through theplurality of pores into the space between the expanded expandablesupport and an internal surface of the tissue.

A location of the catheter may be determined in response to a visual ortactile inspection of one or more indicia positioned on an outer surfaceof a proximal portion of the catheter advanced into the space. The oneor more indicia may comprise a plurality of bands positioned on theouter surface of the proximal portion of the catheter.

In another aspect, a method of providing hemostasis to a tissueenclosing a space within a subject is provided. A blood pressure of thesubject may be received. A catheter having an expandable support may beadvanced into the space enclosed within the tissue. A first internalpressure of the expandable support may be measured. The expandablesupport may be expanded to a second internal pressure greater than theblood pressure of the subject in response to the received blood pressurein order to apply compression to the tissue. The expandable support maycomprise an inflatable balloon, and the expandable support may beexpanded by inflating the inflatable balloon.

In another aspect, an apparatus for providing hemostasis non-invasivelywithin a cavity defined by an internal surface of a bleeding tissuespace of a subject may be provided. The apparatus may comprise anexpandable member configured to be advanced into the cavity through anopening of the tissue space and to apply compression to the internalsurface of the bleeding tissue space. The apparatus may further comprisea processor operably coupled to the expandable support and configured to(i) receive a blood pressure of the subject and (ii) control expansionof the expandable member in response to the received blood pressure. Theprocessor may be further configured to control expansion of theexpandable member so that the expandable member is expanded to aninternal pressure greater than the received blood pressure of thesubject in order to apply compression to the tissue. The processor maybe configured to measure a first internal pressure of the expandablesupport and cause the expandable member to expand to a second internalpressure greater than the blood pressure of the subject in response tothe received blood pressure. The expandable support may comprise aninflatable balloon, and the controller is configured to controlinflation of the inflatable balloon.

In another aspect, an apparatus for providing hemostasis to a prostaticcapsule of a prostate may be provided. The prostatic capsule may enclosea space. The apparatus may comprise a catheter having a distal end and aproximal end and an expandable support assembly adjacent the distal endof the catheter. The catheter may be configured to be advanced into thespace enclosed with the prostatic capsule through an opening into theenclosed space. The expandable support assembly may have an expandedconfiguration configured to anchor along a bladder neck adjacent thedistal opening to the prostatic capsule and at least partially fill thespace enclosed by the prostatic capsule.

The expandable support assembly may comprise an inflatable balloonassembly.

The expanded configuration of the expandable support assembly maycomprise an hourglass shape having a distal bladder region, a proximalprostatic region, and a neck region therebetween. The neck region mayhave a greater wall thickness than one or more of the distal bladderregion and the proximal prostatic region. The distal bladder region maycomprise a rigid balloon.

The expandable support assembly may comprise a proximal expandablesupport and a distal expandable support. The distal expandable supportor the proximal expandable support may be configured to have one or moreof a spherical, toroidal, cylindrical, conical, dual cone, irregular, ordumbbell shape when expanded.

The expandable support assembly may have an expanded shape configured toreduce contact with a verumontanum of the prostate.

At least a portion of an outer surface of the expandable supportassembly may be textured.

The expandable support assembly may comprise one or more of anultrasound hyperechoic material or a radiopaque marker to aidvisualization.

The expandable support assembly may have a non-uniform thickness. Thenon-uniform thickness of the expandable support assembly may beconfigured to provide the expandable support assembly with apredetermined shape. The non-uniform thickness expandable supportassembly may be configured to be expanded in a stepwise manner.

The expandable support assembly may comprise one or more of a compliantmaterial or a non-compliant material.

At least a portion of the expandable support assembly may be coated witha hemostatic agent.

The catheter may comprise one or more indicia disposed on an outersurface of a proximal portion thereof. The one or more indicia may beconfigured to be visually or tactilely inspected to determine a locationof the catheter relative to the tissue. The one or more indicia maycomprise a plurality of bands positioned on the outer surface of theproximal portion of the catheter.

The apparatus may further comprise a bulb positioned on the catheterproximal of the expandable support assembly. The bulb may be configuredto be positioned in the ureter when the expandable support assembly ispositioned in the prostatic capsule so as to minimize migration of thecatheter. The bulb may be expandable or inflatable.

In many embodiments, the apparatus may further comprise a scope tovisualize the enclosed space such as when the tissue sealant isdelivered to the tissue.

In many embodiments, the apparatus may further comprise a scope tovisualize tissue of the enclosed space and a sheath with a balloon. Thescope may comprise a shaft to view the tissue space. The shaft maycomprise a length, and the sheath with the balloon may comprise a lengthfrom a proximal end to a distal end sized smaller than the length of theballoon.

In many embodiments, the treatment agent may comprise a therapeuticagent.

In many embodiments, the treatment agent may comprise a mixture of a geland a therapeutic agent.

In many embodiments, the treatment agent may comprise a chemotherapeuticagent.

In many embodiments, the expandable support may be expanded bysuccessively expanding the expandable support to a plurality ofpredetermined sizes.

In many embodiments, the expandable support has a non-uniform thicknessto provide stepwise expansion.

In many embodiments, tension may be applied to the catheter with theexpandable support expanded within the space or prostatic capsule suchas by coupling a proximal portion of the catheter to a preselectedweight. The preselected weight may be coupled to one or more of astirrup or bed frame. The preselected weight may comprise a fluidcontainer. The tension applied to the catheter by the preselected weightmay be measured such as with a tension measurement element or scalecoupled to the catheter. The preselected weight may be selected inresponse to a measured blood pressure.

In another aspect, an apparatus for maintaining a position of a catheteradvanced into a bodily member may be provided. The apparatus maycomprise an enclosure adapted to enclose the bodily member and thecatheter positioned at least partially within the bodily member. Theenclosure may be shaped to conform and apply pressure to the bodilymember to resist repositioning of the enclosure when enclosing thebodily member. A distal tip of the enclosure may be configured to coupleto a segment of the catheter extending out of the bodily member. Thebodily member may comprise a penis and the catheter may be extending outof a urethral os. The flexible enclosure may be configured to beconcentric with a urethra of the penis when enclosing the penis.

The enclosure may comprise a flexible enclosure. The enclosure may beconfigured to be coupled to the segment of the catheter extending out ofthe bodily member through a retainer element coupled to the segment. Theretainer element may comprise a soft, compliant material to minimizeirritation against tissue of the bodily member. The enclosure may be atleast partially cylindrical in shape.

The catheter may comprise one or more expandable supports configured tobe expanded within one or more of a urethra, a prostatic capsule of aprostate, or a bladder to be lodged therein.

The enclosure may be configured to be coupled to a pelvic or groinmount. The bodily member may comprise a penis, and the pelvic or groinmount may be configured to pull on the enclosure and the penis to aligna urethra of the penis with a urethral sphincter.

The apparatus may further comprise a tension element configured tocouple to one or more of the catheter or the flexible enclosure to alignthe urethra with the urethral sphincter. The tension measurement elementor scale may be configured to couple to the tension element.

In another aspect, a method for maintaining a position of a catheteradvanced into a bodily member may be provided. The bodily member may beenclosed at least partially within an enclosure so that a proximalsegment of the catheter extends from a distal tip of the flexibleenclosure. A distal tip of the enclosure may be coupled to the proximalsegment of the catheter extending out of the bodily member. Theenclosure may be shaped to conform and apply pressure to the bodilymember to resist repositioning of the enclosure when enclosing thebodily member. The bodily member may comprise a penis and the catheteris extending out of a urethral os. To enclose the bodily member at leastpartially within the enclosure, the flexible enclosure may be positionedto be concentric with a urethra of the penis.

The enclosure may comprise a flexible enclosure. The enclosure may becoupled to the segment of the catheter extending out of the bodilymember through a retainer element coupled to the segment. The retainerelement may comprise a soft, compliant material to minimize irritationagainst tissue of the bodily member. The enclosure may be at leastpartially cylindrical in shape.

One or more expandable supports of the catheter may be expanded withinone or more of a urethra, a prostatic capsule of a prostate, or abladder to be lodged therein.

The enclosure may be coupled to a pelvic or groin mount. The bodilymember may comprise a penis, and the enclosure and the penis may bepulled with the pelvic or groin mount to align a urethra of the peniswith a urethral sphincter.

A tension element may be coupled to one or more of the catheter or theflexible enclosure to align the urethra with the urethral sphincter.Tension applied by the tension element may be measured using a tensionmeasurement element or scale coupled thereto.

In another aspect, an apparatus for maintaining a position of a catheteradvanced into a bodily member may be provided. The apparatus maycomprise a base configured to be placed over a pelvis or groin, at leastone extension struts coupled to and extending from the base, and aretainer element coupled to at least one extension strut and configuredto releasably couple to the catheter. The base and the at least oneextension strut may together define an accommodation space for one ormore of a penis or scrotum to pass therethrough.

The base may comprise a pelvic or groin mount contoured to match a shapeof the pelvis or groin. The base may have an opening to allow thecatheter to pass from an exterior of the base to within a perimeter ofthe base and within the accommodation space. The base may be U-shaped.The base may comprise a malleable wire with a soft covering.

The at least one extension strut may be coupled to the base with ahinge, which may be adjustable. Alternatively or in combination, the atleast one extension strut may be coupled to the pelvic or groin mountwith a rigid coupling.

The retainer element may comprise a clamp for clamping one or more ofthe catheter or a medical tape flag coupled to the catheter.

The apparatus may further comprise an adjustable tensioning mechanismcoupled to one or more of the extension struts. The apparatus mayfurther comprise a tension measurement element or scale coupled to theat least one extension strut. The adjustable tensioning mechanism maycomprise a constant force spring configured to apply a substantiallyconstant tension to the catheter over a stroke length of the catheter.The constant force spring may apply a substantially constant tension tothe catheter over a range greater than the stroke length, such as withinabout 25% or even within about 50% more than the stroke length. Thestroke length may be at least 0.5 mm. The stroke length may be in arange of about 0.5 cm to about 8 cm, a range of about 1 cm to about 8cm, a range of about 1 cm to about 5 cm, or a range of about 2 cm toabout 3 cm. A position of the retainer member relative to the base maybe adjustable to adjust a tension applied to the catheter.

One or more of the extension struts may be rounded such as to maximizethe accommodation space.

The apparatus may further comprise a belt or strap coupled to the base.The belt or strap may be configured to be wrapped around and strapped toat least a portion of a patient to maintain a position of the base overthe pelvis or groin.

The at least one extension strut may comprise a plurality of extensionstruts, the base and the plurality of extension struts together definingthe accommodation space. The apparatus may further comprise across-member coupling two or more of the extension struts to oneanother. The retainer element may be positioned between the cross-memberand the base.

The apparatus may be collapsible into a flat package.

In another aspect, a method for maintaining a position of a catheteradvanced into a bodily member may be provided. One or more of a penis orscrotum may be passed through a base, enclosing the one or more of thepenis or scrotum within an accommodation space defined by the base andat least one extension strut coupled to and extending from the base. Thecatheter may be coupled to a retaining element coupled to the at leastone extension strut. The base may comprise a pelvic or groin mountcontoured to match a shape of the pelvis or groin.

A catheter may be passed from an exterior of the base through an openingof the base to within a perimeter of the base and within theaccommodation space.

An angle of the at least one extension strut relative to the base may beadjusted with a hinge coupling the one or more of the extension strutsto the base.

A medical tape may be coupled to the catheter to form a flag and one ormore of the catheter or the medical tape flag may be clamped with aclamp of the retainer element.

A tension applied to the retainer element and the catheter coupledthereto may be adjusted with an adjustable tensioning mechanism coupledto one or more of the extension struts.

A tension applied to the retainer element and the catheter coupledthereto may be measured with a tension measurement element or scalecoupled to the at least one extension strut. The adjustable tensioningmechanism may comprise a constant force spring configured to apply asubstantially constant tension to the catheter over a stroke length ofthe catheter. The constant force spring may apply a substantiallyconstant tension to the catheter over a range greater than the strokelength, such as within about 25% or even within about 50% more than thestroke length. The stroke length may be at least 0.5 mm. The strokelength may be in a range of about 0.5 cm to about 8 cm, a range of about1 cm to about 8 cm, a range of about 1 cm to about 5 cm, or a range ofabout 2 cm to about 3 cm. The tension may be adjusted by adjusting adistance between the retainer element coupling the catheter and the baseover the pelvis or groin.

A belt or strap coupled to the base around may be wrapped around atleast a portion of the patient to maintain a position of the base overthe pelvis or groin.

The at least one extension strut may comprise a plurality of extensionstruts, the base and the plurality of extension struts defining theaccommodation space.

The base, the at least one extension strut, and the retainer element maybe collapsed into a flat package.

In another aspect, a method for providing treatment to a tissueenclosing a space is provided. A catheter may be advanced into the spaceenclosed within the tissue such that at least a portion of the catheteris extending outside of a body of a patient. An expandable member of thecatheter may be expanded within the space enclosed within the tissue.Tension may be applied to the catheter with a constant force spring.

The constant force spring may be coupled to at least the portion of thecatheter extending outside of the body of a patient. The tissue maycomprise a prostatic capsule, and the catheter may extend outside of thebody of the patient from a penis of the patient. The constant forcespring may be coupled to a leg of the patient to apply tension to thecatheter toward feet of the patient. Alternatively, the constant forcespring may be coupled to one or more of an abdomen, a chest, an arm, aneck, or a head of the patient to apply tension to the catheter towardthe head of the patient.

A substantially constant tension may be applied to the catheter over atleast a stroke length of the catheter. The substantially constanttension may be applied within about 25% or about 50% over the strokelength of the catheter. The substantially constant tension may beapplied within about 50% over the stroke length of the catheter. Thestroke length may be in a range of about 0.5 cm to about 8 cm, a rangeof about 1 cm to about 8 cm, a range of about 1 cm to about 5 cm, or arange of about 2 cm to about 3 cm.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A-1C show sectional schematic views of a sealant delivery devicecomprising a catheter, in accordance with embodiments;

FIGS. 2A-2B show sectional schematic views of a sealant delivery devicecomprising a catheter, in accordance with embodiments;

FIGS. 3A-3B show sectional schematic views of another sealant deliverydevice comprising a catheter, in accordance with embodiments;

FIGS. 4A-4B show sectional schematic views of another sealant deliverydevice comprising a catheter, in accordance with embodiments;

FIGS. 5A-5B show sectional schematic views of yet another sealantdelivery device comprising a catheter, in accordance with embodiments;

FIGS. 6A-6C show sectional schematic views of still another sealantdelivery device comprising a catheter, in accordance with embodiments;

FIG. 7A is a schematic illustration of a device suitable for performingintraurethral prostatic tissue debulking, in accordance withembodiments;

FIGS. 7B-7E show sectional schematic views of the use of the device ofFIG. 7A in performing prostatic tissue debulking; in accordance withembodiments;

FIG. 7F shows a sectional schematic view of rapid exchange of a carrierwhen the linkage is coupled to the elongate element anchored to a targetlocation of an organ, in accordance with embodiments;

FIG. 7G shows a magnified perspective view of the alignment of thedistal tip of the carrier with the proximal end of the linkage to insertthe carrier tube as in FIG. 7F;

FIG. 7H shows a magnified perspective view of the carrier advancedtoward a locking structure on the proximal end of the linkage as in FIG.7F;

FIG. 7I shows a magnified perspective view of the carrier locked to thelinkage as in FIGS. 7F and 7G;

FIGS. 8A-8B show sectional schematic views of sealant delivery devicescomprising a tissue resection device and sealant applicator nozzle, inaccordance with embodiments;

FIG. 9 shows a flowchart of a method of providing hemostasis within atissue cavity, in accordance with embodiments;

FIGS. 10A-10G show sectional schematic views of sealant delivery devicescomprising a scope, in accordance with embodiments;

FIGS. 11A-11D show sectional schematic views of a sealant deliverydevice comprising a catheter, in accordance with embodiments;

FIGS. 12A-12B show sectional schematic views of another sealant deliverydevice comprising a catheter, in accordance with embodiments;

FIGS. 13A-13D show sectional schematic of yet another sealant deliverydevice comprising a catheter, in accordance with embodiments;

FIG. 14 shows a flowchart of a method of providing hemostasis within atissue cavity, in accordance with embodiments;

FIGS. 15A-15C show sectional schematic views of an exemplarysingle-balloon sealant delivery device delivering a self-expanding gelsealant, in accordance with embodiments;

FIGS. 16A-16C show sectional schematic views of an exemplarydouble-balloon sealant delivery device delivering a self-expanding gelsealant, in accordance with embodiments;

FIGS. 17A-17C show sectional schematic views of an exemplarysingle-balloon sealant delivery device delivering a self-expanding gelsealant without a balloon to inhibit flow into the bladder, inaccordance with embodiments;

FIGS. 18A-18D show sectional schematic views of an exemplarytriple-balloon sealant delivery device delivering a self-expanding gelsealant, in accordance with embodiments;

FIGS. 19A-19D show sectional schematic views of a sealant deliverydevice comprising a catheter and polymer sheath, in accordance withembodiments;

FIGS. 20A-20B show sectional schematic views of a sealant deliverydevice comprising an elastic sheath, in accordance with embodiments;

FIG. 21A shows a front section view of a prostate, urethra, and bladder,in accordance with embodiments;

FIG. 21B shows a side section view of a prostate, urethra, and bladder,in accordance with embodiments;

FIGS. 22A-22E show various sectional schematic views of a catheter withinflatable balloon assembly comprising a single compliant balloon toprovide compression hemostasis, in accordance with embodiments;

FIGS. 23A-23C show various sectional schematic views of a catheter withinflatable balloon assembly comprising two balloons to providecompression hemostasis, in accordance with embodiments;

FIGS. 24A-24D show various sectional schematic views a catheter withinflatable balloon assembly comprising adjustable balloons to providecompression hemostasis, in accordance with embodiments;

FIGS. 25A-25F show various sectional schematic views of a catheter withinflatable balloon assembly shaped to provide compression hemostasis andreduce compression of the verumontanum, in accordance with embodiments;

FIG. 26 shows a section view of a catheter with inflatable balloonassembly comprising a urethral bulb to minimize catheter migration, inaccordance with embodiments;

FIG. 27A shows a section view of a bodily member prior to positioningwith a flexible enclosure, in accordance with embodiments;

FIG. 27B shows a section view of a catheter coupled to a flexibleenclosure adapted to resist repositioning and maintain a position of abodily member, in accordance with embodiments;

FIG. 27C shows a perspective section view of a saddle traction device inuse, in accordance with embodiments;

FIG. 27D shows a schematic view of an operating room bed-mounted tensionelement, in accordance with embodiments;

FIG. 28 shows a schematic of a sealant delivery device comprising aprocessor, in accordance with embodiments;

FIG. 29 shows a section view of a catheter comprising distance markersto monitor catheter migration, in accordance with embodiments;

FIGS. 30A, 30B, 30C, and 30D show front, side, top, and perspectiveviews, respectively, of a saddle traction device configured to resistrepositioning of an anatomical member and catheter enclosed therewithin,in accordance with embodiments;

FIGS. 31A, 31B, 31C, and 31D show front, side, top, and perspectiveviews, respectively, of another saddle traction device configured toresist repositioning of an anatomical member and catheter enclosedtherewithin, in accordance with embodiments;

FIGS. 32A, 32B, 32C, and 32D show front, side, top, and perspectiveviews, respectively, of another saddle traction device configured toresist repositioning of an anatomical member and catheter enclosedtherewithin, in accordance with embodiments;

FIG. 33 shows a catheter provided with a “flag” to assist withmaintaining a fixed position of the catheter with various saddletraction devices, in accordance with embodiments;

FIGS. 34A, 34B, 34C, and 34D show front, side, top, and perspectiveviews, respectively, of another saddle traction device configured toresist repositioning of an anatomical member and catheter enclosedtherewithin, in accordance with embodiments;

FIGS. 35A, 35B, 35C, and 35D show front, side, top, and perspectiveviews, respectively, of another saddle traction device configured toresist repositioning of an anatomical member and catheter enclosedtherewithin, in accordance with embodiments;

FIGS. 36A, 36B, 36C, and 36D show front, side, top, and perspectiveviews, respectively, of another saddle traction device configured toresist repositioning of an anatomical member and catheter enclosedtherewithin, in accordance with embodiments;

FIGS. 37A, 37B, 37C, and 37D show front, side, top, and perspectiveviews, respectively, of another saddle traction device configured toresist repositioning of an anatomical member and catheter enclosedtherewithin, in accordance with embodiments;

FIGS. 38A, 38B, 38C, 38D, and 38E show front, side, top, perspective,and magnified views, respectively, of another saddle traction deviceconfigured to resist repositioning of an anatomical member and catheterenclosed therewithin, in accordance with embodiments;

FIGS. 39A, 39B, 39C, and 39D show front, side, top, and perspectiveviews, respectively, of another saddle traction device configured toresist repositioning of an anatomical member and catheter enclosedtherewithin, in accordance with embodiments;

FIGS. 40A, 40B, 40C, and 40D show front, side, top, and perspectiveviews, respectively, of another saddle traction device configured toresist repositioning of an anatomical member and catheter enclosedtherewithin, in accordance with embodiments;

FIGS. 41A, 41B, 41C, 41D, and 41E show front, side, top, perspective,and perspective views, respectively, of another saddle traction deviceconfigured to resist repositioning of an anatomical member and catheterenclosed therewithin, in accordance with embodiments; and

FIG. 42 shows a schematic illustration of a catheter extending from ananatomical member and coupled to a constant force spring, in accordancewith embodiments.

DETAILED DESCRIPTION OF THE INVENTION

In the following detailed description, reference is made to theaccompanying figures, which form a part hereof. In the figures, similarsymbols typically identify similar components, unless context dictatesotherwise. The illustrative embodiments described in the detaileddescription, figures, and claims are not meant to be limiting. Otherembodiments may be utilized, and other changes may be made, withoutdeparting from the scope of the subject matter presented herein. It willbe readily understood that the aspects of the present disclosure, asgenerally described herein, and illustrated in the figures, can bearranged, substituted, combined, separated, and designed in a widevariety of different configurations, all of which are explicitlycontemplated herein.

The methods and apparatus of the present disclosure is well suited forcombination with the following patents and applications: U.S. Pat. No.7,882,841, issued Feb. 8, 2011, entitled “MINIMALLY INVASIVE METHODS ANDDEVICES FOR THE TREATMENT OF PROSTATE DISEASES”; U.S. Pat. No.8,814,921, issued Aug. 26, 2014, entitled “TISSUE ABLATION AND CAUTERYWITH OPTICAL ENERGY CARRIED IN FLUID STREAM”; U.S. Pat. No. 9,232,959,entitled “MULTI FLUID TISSUE RESECTION METHODS AND DEVICES”;International Application No. PCT/US2013/028441, filed on Feb. 28, 2013,entitled “AUTOMATED IMAGE-GUIDED TISSUE RESECTION AND TREATMENT”;International Application No. PCT/US2014/054412, filed on Sep. 5, 2014,entitled “AUTOMATED IMAGE-GUIDED TISSUE RESECTION AND TREATMENT”;International Application No. PCT/US2015/037521, filed Jun. 24, 2015,entitled “TISSUE SAMPLING AND CANCER TREATMENT METHODS AND APPARATUS”;International Application No. PCT/US2015/038605, filed on Jun. 30, 2015,entitled “FLUID JET TISSUE RESECTION AND COLD COAGULATION (AQUABLATION)METHODS AND APPARATUS”; and International Application No.PCT/US2015/048695, filed on Sep. 4, 2015, entitled “PHYSICIAN CONTROLLEDTISSUE RESECTION INTEGRATED WITH TREATMENT MAPPING OF TARGET ORGANIMAGES”, the entire disclosures of which are incorporated herein byreference, and suitable for combination in accordance with embodimentsdisclosed herein.

As used herein, the terms proximal and distal in the context of theapparatus refer to proximal and distal as referenced from the apparatusoutside the patient, such that proximal may refer to components outsidethe patient or nearer the operator and distal may refer to componentsinside the patient or further from the operator.

As used herein, the terms proximal and distal in the context ofanatomical locations are with respect to the operator of the apparatus,such that proximal may refer to anatomical locations nearer the operatorand distal may refer to anatomical locations further from the operator.

As used herein, the terms “cavity”, “closed tissue volume” and “space”are used interchangeably to refer to a space enclosed within a tissue.

Although specific reference is made to treatment of the prostate, themethods and systems disclosed herein can be used with many tissues. Forexample, the embodiments disclosed herein may be used to treat anytissue cavity defined by an internal surface of a bleeding tissuevolume. The embodiments described herein may provide hemostasis to atissue enclosing a space to inhibit bleeding from the tissue into thespace. Embodiments as disclosed herein may be used to treat any tissuecavity comprising a proximal opening and a distal opening, the proximaland distal openings allowing the tissue volume to fluidly communicatewith other organs or parts of the body adjacent the tissue volume. Forexample, although specific reference is made to the advancement of thehemostasis device through the urethra into the prostate, and through thebladder neck into the bladder, a hemostasis device as described hereinmay be advanced through any proximal opening of a tissue cavity into thecavity, and through any distal opening of the tissue cavity into anotherorgan or body part adjacent the tissue volume.

The methods and systems disclosed herein relate to the administration ofa hemostatic material or sealant to fill in whole, or in part, anybleeding closed tissue volume. Such tissue volumes may comprise tissuespaces or voids occurring naturally, for example an aneurysm, fissure,or postpartum hemorrhage of the uterus. Such tissue volumes may forexample be formed as a result of tissue removal of unnecessary orundesirable growths, fluids, cells, or tissues. The methods and systemsdisclosed herein are well-suited for treating closed tissue volumesremaining after tumor resection, endometrial ablation, polyp removal,cyst removal, and the like.

The methods and systems disclosed herein are well-suited for treatingmany types of closed tissue volumes such as within the nose, stomach,eye, spine, brain, rectum, prostate, uterus, cervix, liver, kidney,bowel, pancreas, lung, breast, muscle, and the like.

As used herein, the term “sealant” may refer to a hemostatic agent, agel, a flowable material containing particles, a tissue sealant, oradhesive. Further, the sealants used herein may be combined withtherapeutic agents such as anesthetics, radiopharmaceuticals,antibiotics, chemotherapeutics, and the like.

The methods and systems disclosed herein may for example employ one ormore of the following sealants commonly used in urologic surgerypractices: BioGlue® Surgical Adhesive (CryoLife), Surgicel® (Ethicon),Floseal® Hemostatic Matrix (Baxter Healthcare), TISSEL® (BaxterHealthcare), COSEAL Surgical Sealant (Baxter Healthcare), TachoSil®(Baxter Healthcare), SPONGOSTAN™ Absorbable Haemostatic Gelatin Sponge(Ethicon), Glubran 2™ (MediVogue), Hemaseel APR™ (HaemacureCorporation), or the like. Other sealants which may be used includeDermabond™, Gelfoam®, Surgifoam™, Avitene®, Helistat®, Superstat®,Instat®, Surgiflo™, Thrombinar®, rFVIIa, and the like. Possible sealantclasses which may be used may include fibrin sealants, PEG polymers,biologic surgical GRF glues, thrombins, polymeric hydrogels, topicalhemostats, anti-fibrinolytics, matrix hemostats, and other hemostaticagents. Sealants may be liquid, gel, or dry. Other agents that may beapplied may include Afrin® (oxymetazoline), epinephrine, orplatelet-rich plasma (PRP).

The methods and systems disclosed herein may be configured to apply asealant to the internal surface of a tissue space without occluding aproximal opening of the tissue space, a distal opening of the tissuespace, or a path extending therebetween with the hemostatic sealant.

As used herein, the terms closed tissue volume, tissue cavity, tissuespace, and tissue void may be used interchangeably.

FIGS. 1A-1C show an embodiment of a minimally invasive sealant deliverydevice. The sealant delivery device may be a modified Foley catheter forexample. A conventional three-way Foley irrigation catheter is a largeindwelling urinary catheter comprising three lumens. The first lumen maybe used to inflate a distal balloon used to retain the catheter in thebladder. The second lumen may be used for irrigation. The third lumenmay be used for drainage of urine. The catheter simultaneously allowsfluid to run into and drain out of the bladder. Foley catheters aretypically large enough (e.g. 16-24ch) to accommodate the passage ofclots from the bladder.

The sealant delivery device may for example be used to deliver ahemostatic agent or sealant into a cavity created by tissue resection inthe prostatic capsule. The cavity may be defined by an internal surfaceof the tissue volume, such as the resected surface of the prostaticcapsule. The sealant delivery device may comprise a catheter comprisinga distal balloon and a proximal balloon and may be delivered through theurethra such that distal balloon and proximal balloon are fully insertedinto the bladder and prostatic capsule, respectively. The catheter maybe sized and shaped to the closely fit within the proximal opening ofthe prostatic capsule to the urethra, such that when the catheter isadvanced into the prostatic capsule, the catheter body substantiallyseals off the proximal opening. The distal balloon may be positionedadjacent to a distal opening of the tissue space so as to seal thebladder upon inflation and close off the tissue resection cavity. Theproximal balloon may be positioned so as to reside within the resectioncavity of the prostatic capsule.

The catheter may further comprise one or more of an irrigation port, adrainage port, an inflation port for the distal bladder balloon, aninflation port for the proximal prostatic balloon, or a sealant infusionport. The inflation ports may be fluidly coupled to the balloons andused to inflate the distal and proximal balloons, respectively. Theirrigation and drainage ports may be used to introduce fluids, such assaline and medications, into the bladder and remove fluids, such asurine, from the bladder, respectively, via one or more ports at thedistal end of the catheter. The prostatic capsule may be sealed off fromthe bladder while still allowing for the passage of fluids to and fromthe bladder when the distal balloon is inflated using the inflation portfor the distal balloon. The sealant infusion port may be coupled to asealant delivery port and used to deliver sealant to the resectioncavity prior to, during, or after inflation of the distal balloon.

FIG. 1A shows delivery of a sealant 701 into the resection cavity 901 ofthe prostatic capsule 900. The catheter may be advanced into theprostatic capsule 900 through the proximal opening 902 of the prostaticcapsule 900. The sealant 701 may be introduced or infused into thecatheter through a sealant infusion port 801 located near the proximalend of the catheter. The sealant 701 may be delivered to the resectioncavity 901 via a sealant delivery port 807 in fluid communication withthe sealant infusion port 801 and located near the distal end of thecatheter residing inside the prostatic capsule 900. The sealant deliveryport 807 may, for example, be located between the distal balloon 808 andthe proximal balloon 806.

FIG. 1B shows the resection cavity 901 filled with the sealant 701 afterdelivery with the proximal balloon 806 in an unexpanded configuration.The distal balloon 808 may be inflated so as to completely seal off thebladder B from the prostatic capsule 900 at the distal opening 903 ofthe prostatic capsule 900 comprising the bladder neck, such that onlythe resection cavity 901 receives the sealant 701. Alternatively, thedistal balloon 808 may be inflated so as to partially, or nearlycompletely, seal off the bladder B from the prostatic capsule 900. Forexample, the distal balloon 808 may be inflated so as to leave a smallspace between the bladder neck and the distal balloon 808. This mayallow a small amount of sealant 701 to reach the bladder neck itself, asshown in FIG. 1B. This may be advantageous in situations where thebladder neck area is the source of bleeding, as the bladder neck commonlocation of bleeding following tissue resection in the prostatic capsule900. The catheter body may seal off the proximal opening 902 while thecatheter is positioned with the cavity, such that the sealant does notenter the urethra.

FIG. 1C shows the inflation of the proximal balloon 806 after deliveryof the sealant 701 to an expanded configuration. The proximal balloon806 may be inflated prior to or during delivery of the sealant 701 inorder to reduce the amount of sealant 701 need to coat the edge of thecavity. The proximal balloon 806 may be inflated in order to compressthe sealant against an internal surface of the cavity, for example, thecavity edge 904 at the periphery of the resection cavity 901, thusensuring delivery to the entire tissue area of the cavity edge 904. Thecatheter may be left in the patient with the proximal balloon 806inflated for an amount of time to ensure hemostasis has occurred. Theamount of time for hemostasis may depend on the sealant used and mayrange from minutes to hours to overnight.

While the sealant delivery port 807 may be disposed proximally of thedistal end of the catheter of shown, it will be understood by one ofordinary skill in the art that the sealant delivery port in this or anyembodiment may be disposed anywhere along the catheter to deliver thesealant 701 to the cavity as desired. For example, the sealant deliveryport may be disposed near the proximal opening 902 of the tissue or thedistal opening 903 of the tissue. The sealant delivery port may forexample be disposed between the proximal and distal balloons near thedistal tissue opening as shown or proximal to the proximal balloon 806near the proximal tissue opening. Alternatively, the catheter maycomprise a single balloon, for example the proximal balloon 806 disposedin the cavity. The sealant delivery port may be disposed proximally ordistally to the proximal balloon 806. Infusion of sealant and expansionof the proximal balloon 806 may deliver sealant 701 to the cavity edge904 and may optionally urge sealant 701 towards the bladder neck toreduce bleeding in locations which are not in contact with the proximalballoon 806.

FIGS. 2A-2B show another embodiment of a minimally invasive sealantdelivery device. The sealant delivery device may, for example, be usedto deliver a hemostatic agent or sealant into a cavity created by tissueresection in the prostatic capsule. The sealant delivery device maycomprise a catheter comprising a distal balloon and a proximal and maybe delivered through the urethra such that distal balloon and proximalballoon are fully inserted into the bladder and prostatic capsule,respectively. The distal balloon may be positioned adjacent to a distalopening of the tissue space so as to seal the bladder upon inflation andclose off the tissue resection cavity. The proximal balloon may bepositioned adjacent the proximal opening of the resection cavity so asto reside within the resection cavity of the prostatic capsule and sealthe cavity at the urethra upon expansion. Positioning the proximalballoon at the urethra may allow for homogeneous fill of sealant withinthe resection cavity.

The catheter may further comprise one or more of an irrigation port 805,a drainage port 802, an inflation port 804 for the distal bladderballoon, an inflation port 803 for the proximal prostatic balloon, or asealant infusion port 801 as previously described herein. The inflationports may be fluidly coupled to the balloons and used to inflate thedistal and proximal balloons, respectively. The sealant infusion portmay be used to deliver sealant to the resection cavity prior to, during,or after inflation of the distal balloon.

FIG. 2A shows delivery of a sealant 701 into the resection cavity 901 ofthe prostatic capsule 900. The catheter may be advanced through theurethra into the cavity via the proximal opening 902. The sealant 701may be infused into the catheter through a sealant infusion port 801located near the proximal end of the catheter and positioned distallywith respect to the proximal balloon 806. The sealant 701 may bedelivered to the resection cavity 901 via a sealant delivery port 807located on the catheter residing inside the prostatic capsule 900. Thesealant delivery port 807 may, for example, be located between thedistal balloon 808 and the proximal balloon 806. The proximal balloon806 may be inflated prior to delivery of the sealant. The distal balloon808 may be inflated so as to at least partially or completely seal offthe bladder B from the prostatic capsule 900 at the bladder neck BN aspreviously described herein.

FIG. 2B shows the resection cavity 901 filled with the sealant 701 afterdelivery. The catheter may comprise a sealant overflow port 807 adjacentthe sealant delivery port 807 so as to remove excess sealant 702 fromthe resection cavity 901 after the cavity has been completely filled.The excess sealant 702 may be removed to the bladder B, where it canthen be taken up by the catheter for removal from the body through thedrainage port 802. The sealant overflow port 807 may further help toremove fluid from the resection cavity 901 as the sealant infuses intothe cavity in order to promote a homogenous mixture within the cavity.Removal of excess sealant 702 may be controlled such that inflow ofsealant through the sealant delivery port 807 results in a positivepressure within the resection cavity 901. The positive pressure mayensure even distribution of the sealant to the cavity edge 904 withoutthe use of a balloon as in the embodiments of FIGS. 1A-1C. The positivepressure may also be useful in opening a cavity which has collapsedfollowing tissue resection. The size of the sealant overflow port 807can vary outflow resistance and may be used to modulate the amount ofpressure that accumulates within the resection cavity 901. Alternativelyor in combination, the pressure of the sealant inside the catheter maycause the sealant overflow port 807 to distend, thereby encouragingoutflow of the sealant and maintenance of the positive pressure withinthe resection cavity 901. The catheter may be left in the patient withsaid positive pressure for an amount of time to ensure hemostasis hasoccurred. The amount of time for hemostasis may depend on the sealantused and may range from minutes to hours to overnight.

FIGS. 3A-3B show another embodiment of a minimally invasive sealantdelivery device. The sealant delivery device may, for example, be usedto deliver a hemostatic agent or sealant into a cavity created by tissueresection in the prostatic capsule 900. The sealant delivery device maycomprise a catheter comprising a distal balloon 808 and a proximalballoon 806 and may be delivered through the urethra such that distalballoon 808 and proximal balloon 806 are fully inserted into the bladderB and prostatic capsule 900, respectively. The distal balloon 808 may bepositioned adjacent to a distal opening 903 of the tissue space so as toseal the bladder B upon inflation and close off the tissue resectioncavity 901. The proximal balloon 806 may be positioned so as to residewithin the resection cavity 901 of the prostatic capsule 900.

The catheter may further comprise one or more of an irrigation port 805,a drainage port 802, an inflation port 804 for the distal bladderballoon, or an inflation port 803 for the proximal prostatic balloon.The inflation ports may be fluidly coupled to the balloons and used toinflate the distal and proximal balloons, respectively. The irrigationand drainage ports may be used as previously described herein. Theinflation port 803 for the proximal balloon may, for example, comprise asealant infusion port, for example, a sealant balloon infusion port 801.The sealant balloon infusion port 801 may be used to deliver sealant 701to the resection cavity 901 prior to, during, or after inflation of thedistal balloon 808.

FIG. 3A shows delivery of a sealant 701 into the resection cavity 901 ofthe prostatic capsule 900. The sealant may be infused into the proximalballoon 806 through a sealant balloon infusion port 801 located near theproximal end of the catheter. The proximal balloon 806 may, for example,be porous and may comprise one or more sealant delivery pores 810.Infusion of the sealant 701 into the proximal balloon 806 may cause theballoon to distend and thereby allow the sealant to ooze or seep intothe resection cavity 901. The distal balloon 808 may be inflated so asto completely seal off the bladder B from the prostatic capsule 900 atthe bladder neck BN such that only the resection cavity 901 receives thesealant 701. Alternatively, the distal balloon 808 may be inflated so asto partially, or nearly completely, seal off the bladder B from theprostatic capsule 900 as previously described herein.

FIG. 3B shows the resection cavity 901 filled with the sealant 701 afterdelivery. The proximal balloon 806 has been inflated, allowing for therelease of the sealant into the resection cavity 901. Pressure generatedin the proximal balloon 806 by the infusion of sealant 701 as itinflates may lead to stretching of the sealant delivery pores 810. Asthe balloon inflates, the pores 810 stretch and sealant is allowed toflow out of the proximal balloon 806 into the resection cavity 901. Theproximal balloon 806 may be configured such that the rates of sealantdelivery and balloon inflation are controllable, for example, bycontrolling the strength of the material of the proximal balloon 806 orthe size of the pores 810. The proximal balloon 806 may be inflated inorder to compress the sealant into the cavity edge 904 at the peripheryof the resection cavity 901, thus ensuring delivery to the entire tissuearea of the cavity edge 904. The catheter may be left in the patientwith the proximal balloon 806 inflated for an amount of time to ensurehemostasis has occurred. The amount of time for hemostasis may depend onthe sealant used and may range from minutes to hours to overnight.

It will be understood by one of ordinary skill in the art that any ofthe embodiments described herein may comprise any number of balloons orexpandable supports as desired. For example, the device shown in FIGS.3A-3B may comprise a single balloon, for example the proximal balloon. Acatheter comprising the proximal balloon with a plurality of pores maybe used to deliver sealant into the resection cavity of the prostaticcapsule as described herein.

FIGS. 4A-4B show another embodiment of a minimally invasive sealantdelivery device. The sealant delivery device may, for example, be usedto deliver a hemostatic agent or sealant into a cavity created by tissueresection in the prostatic capsule. The sealant delivery device maycomprise a catheter comprising a distal balloon and a proximal balloonand may be delivered through the urethra such that distal balloon andproximal balloon are fully inserted into the bladder and prostaticcapsule respectively. The distal balloon may be positioned adjacent to adistal opening of the tissue space so as to seal the bladder uponinflation and close off the tissue resection cavity. The proximalballoon may be positioned so as to reside within the resection cavity ofthe prostatic capsule.

The catheter may further comprise one or more of an irrigation port 805,a drainage port 802, an inflation port 804 for the distal bladderballoon, or an inflation port 803 for the proximal prostatic balloon.The inflation ports may be fluidly coupled to the balloons and used toinflate the distal and proximal balloons, respectively. The irrigationand drainage ports may be used as previously described herein. Theproximal balloon may comprise a scaffold member disposed over at least aportion of an external surface of the proximal balloon.

FIG. 4A shows a sealant delivery device comprising a sealant scaffoldmember 811 in the resection cavity 901 of the prostatic capsule 900. Thesealant scaffold 811 may, for example, be a mesh, a composite mesh, acollagen membrane, a patch, an adhesive, or the like. Inflation of theproximal balloon 806 may expand the scaffold member 811 to the cavityedge 904 for hemostasis. The scaffold member 811 may be biodegradable.The scaffold member 811 may be embedded with a hemostatic agent or gelto enhance hemostasis. The scaffold member 811 may not be embedded witha hemostatic agent or gel to enhance hemostasis and may instead promotehemostasis by acting as a mechanical seal. The scaffold member 811 maybe delivered to the cavity edge 904 so as to apply pressure to promotehemostasis until the scaffold member 811 dissolves or is removed. Thedistal balloon 808 may be inflated so as to completely seal off thebladder B from the prostatic capsule 900 at the bladder neck BN suchthat only the resection cavity 901 receives the sealant scaffold 811.

FIG. 4B shows the inflation of the proximal balloon 806 and delivery ofthe sealant scaffold 811 to the cavity edge 904. The proximal balloon806 may be inflated in order to compress the sealant scaffold into thecavity edge 904 at the periphery of the resection cavity 901, thusensuring delivery to the entire tissue area of the cavity edge 904. Thecatheter may be left in the patient with the proximal balloon 806inflated for an amount of time to ensure hemostasis has occurred. Theballoon and scaffold may be collapsed together for removal.Alternatively, the sealant scaffold may be configured so as to remainexpanded after the proximal balloon 806 has collapsed. The sealantscaffold may, for example, be biodegradable and may thus be left in theresection cavity 901 to absorb or dissolve over time after removal ofthe catheter. The amount of time for hemostasis to occur may depend onthe sealant used and may range from minutes to hours to overnight.

FIGS. 5A-5B show another embodiment of a minimally invasive sealantdelivery device. The sealant delivery device may be substantiallysimilar to the embodiment of FIGS. 4A-4B. The sealant delivery devicemay for example be used to deliver a hemostatic agent or sealant into acavity created by tissue resection in the prostatic capsule 900. Thesealant delivery device may comprise a catheter comprising a distalballoon 808 and a proximal and may be delivered through the urethra suchthat distal balloon 808 and proximal balloon 806 are fully inserted intothe bladder B and prostatic capsule 900, respectively. The distalballoon 808 may be positioned adjacent to a distal opening of the tissuespace so as to seal the bladder B upon inflation and close off thetissue resection cavity 901. The proximal balloon 806 may be positionedso as to reside within the resection cavity 901 of the prostatic capsule900.

The catheter may further comprise one or more of an irrigation port 805,a drainage port 802, an inflation port 804 for the distal bladderballoon, or an inflation port 803 for the proximal prostatic balloon.The inflation ports may be fluidly coupled to the balloons and used toinflate the distal and proximal balloons, respectively. In someembodiments, the same port may be used to inflate both the distal andproximal balloons simultaneously. The irrigation and drainage ports maybe used as previously described herein. The proximal balloon 806 maycomprise a scaffold member 811 disposed over at least a portion of anexternal surface of the proximal balloon 806. The distal balloon 808 maycomprise at least a portion of the scaffold member 811 disposed over atleast a portion of an external surface of the distal balloon 808 suchthat the scaffold member 811 extends distally through the bladder neckBN when the catheter is positioned in the urethra as previouslydescribed herein.

FIG. 5A shows a sealant delivery device comprising a sealant scaffoldmember 811 in the resection cavity 901 of the prostatic capsule 900. Thesealant scaffold 811 may for example be a mesh, a composite mesh, acollagen membrane, a patch, an adhesive, or the like. Inflation of theproximal balloon 806 may expand the scaffold member 811 to the cavityedge 904 for hemostasis. The scaffold member 811 may be biodegradable.The scaffold member 811 may be embedded with a hemostatic agent or gelto enhance hemostasis. A portion of the scaffold member 811 may extendto the distal balloon 808 such that inflation of the distal balloon 808expands the scaffold member 811 to the bladder neck BN. The distalballoon 808 may be inflated so as to completely seal off the bladder Bfrom the prostatic capsule 900 at the bladder neck BN such that only theresection cavity 901 and the tissue space near or in the bladder neck BNreceive the sealant scaffold 811.

FIG. 5B shows the inflation of the proximal balloon 806 and distalballoon 808 for delivery of the sealant scaffold 811 to the cavity edge904 and bladder neck BN. The proximal balloon 806 may be inflated inorder to compress the sealant scaffold 811 into the cavity edge 904 atthe periphery of the resection cavity 901, thus ensuring delivery to theentire tissue area of the cavity edge 904. The distal balloon 808 may beinflated in order to compress the sealant scaffold 811 into the cavityedge 904 at the bladder neck BN. This may allow a small amount ofsealant to reach the bladder neck itself, which may be advantageous insituations where the bladder neck area is the source of bleeding aspreviously described herein. The catheter may be left in the patientwith one or more of the proximal balloon 806 or distal balloon 808inflated for an amount of time to ensure hemostasis has occurred. Theproximal balloon 806, distal balloon 808, and scaffold 811 may becollapsed together for removal. Alternatively, the sealant scaffold 811may be configured so as to remain expanded after the proximal balloon806 and distal balloon 808 have collapsed. The sealant scaffold 811 may,for example, be biodegradable and may thus be left in the resectioncavity 901 to absorb or dissolve over time after removal of thecatheter. The amount of time for hemostasis to occur may depend on thesealant used and may range from minutes to hours to overnight.

FIGS. 6A-6C show yet another embodiment of a minimally invasive sealantdelivery device. The sealant delivery device may, for example, be usedto deliver a hemostatic agent or sealant into a cavity created by tissueresection in the prostatic capsule 900. The sealant delivery device maycomprise a catheter comprising a distal balloon 808 and a proximalballoon 806 and may be delivered through the urethra such that distalballoon 808 and proximal balloon 806 are fully inserted into the bladderB and prostatic capsule 900, respectively. The distal balloon 808 may bepositioned adjacent to a distal opening of the tissue space so as toseal the bladder B upon inflation and close off the tissue resectioncavity 901. The proximal balloon 806 may be positioned so as to residewithin the resection cavity 901 of the prostatic capsule 900. Theproximal balloon 806 may be an actuatable balloon.

The catheter may further comprise one or more of an irrigation port 805,a drainage port 802, an inflation port 804 for the distal bladderballoon, an inflation port 803 for the proximal prostatic balloon, or asealant infusion port 801. The inflation ports may be fluidly coupled tothe balloons and used to inflate the distal and proximal balloons,respectively. The irrigation and drainage ports may be used aspreviously described herein. The sealant infusion port 801 may be usedto deliver sealant to the resection cavity 901 prior to, during, orafter inflation of the distal balloon 808.

FIG. 6A shows delivery of a sealant 701 into the resection cavity 901 ofthe prostatic capsule 900. The sealant may be infused into the catheterthrough a sealant infusion port 801 located near the proximal end of thecatheter. The sealant 701 may be delivered to the resection cavity 901via a sealant delivery port 807 located on the catheter residing insidethe prostatic capsule 900. The sealant delivery port 807 may for examplebe located between the distal balloon 808 and the proximal balloon 806,for example.

The distal balloon 808 may be inflated so as to completely seal off thebladder B from the prostatic capsule 900 at the bladder neck such thatonly the resection cavity 901 receives the sealant, as shown in FIG. 6C.Alternatively, the distal balloon 808 may be inflated so as topartially, or nearly completely, seal off the bladder B from theprostatic capsule 900 as previously described herein. This may allow asmall amount of sealant to reach the bladder neck itself, as shown inFIG. 6B. This may be advantageous in situations where the bladder neckarea is the source of bleeding, as the bladder neck common location ofbleeding following tissue resection in the prostatic capsule 900.

The proximal balloon 806 may be inflated after sealant delivery andlongitudinally actuated so as to help spread or “paint” the sealantevenly along the cavity edge 904. The proximal balloon 806 may movealong a longitudinal axis of the catheter between the proximal opening902 and the distal opening of the cavity. FIG. 6B shows the inflation ofthe proximal balloon 806 after delivery of the sealant. Alternatively,the proximal balloon 806 may be inflated prior to or during delivery ofthe sealant in order to reduce the amount of sealant need to coat theedge of the cavity. The proximal balloon 806 may be inflated in order tocompress the sealant into the cavity edge 904 at the periphery of theresection cavity 901. The proximal balloon 806 may be actuated to helpspread the sealant through movement in a distal direction. FIG. 6C showsthe proximal balloon 806 at the distal end of resection cavity 901following the distal movement DM. The proximal balloon 806 may furtherbe actuated to move in a proximal direction PM. The balloon may forexample be moved back and forth, distally and proximally, to help spreadthe sealant along the cavity edge 904 as it moves within the resectioncavity 901. The proximal balloon 806 may be manually actuated throughtension force-stretching or through a mechanical linkage to the proximalballoon 806. Differing material properties along the catheter, forexample, an accordion-like section, an elastic section, or built-insprings in the resection cavity 901, may facilitate transmission ofmanual movement primarily to the proximal balloon 806. The use of such a“painting” technique may result in a reduced amount of sealant used asthe proximal balloon 806 scrubs the sealant across the cavity edge 904.The catheter may be left in the patient with the proximal balloon 806inflated for an amount of time to ensure hemostasis has occurred. Theamount of time for hemostasis may depend on the sealant used and mayrange from minutes to hours to overnight.

Optionally, in any of the embodiments described herein, at least aportion of the sealant may be stored in and delivered from one or morebuilt-in reservoirs within the catheter, alternatively to or incombination with the delivery of sealant from a sealant infusion port atthe proximal end of the catheter. The sealant may comprise one or morecomponents which, when mixed, form an active hemostatic agent. Forexample, the sealant may comprise a first component and a secondcomponent. The first component and the second component may behemostatically inert when unmixed. The first component and the secondcomponent may be mixed to form an active sealant. The sealant deliverydevice of any of the embodiments described herein may comprise one ormore built-in reservoirs in which one or more of the first component orthe second component may be stored prior to mixing. The sealant deliverydevice may be adapted to mix the first component with the secondcomponent prior to or during delivery into the resection cavity in orderto create and deliver the active hemostatic sealant. Mixing may forexample occur during balloon inflation. Alternatively or in combination,mixing may occur due to mechanical agitation prior to, during, or afterdelivery to the resection cavity.

Optionally, any of the embodiments described herein may further comprisea targeted sealant delivery catheter, which may be provided within orseparately from a main catheter of the sealant delivery device (e.g.,modified Foley catheter). The targeted sealant delivery catheter maycomprise a small-lumen catheter capable of being navigated to specificlocations within the tissue space. For example, the targeted sealantdelivery catheter may be operably coupled with an actuation mechanism(e.g., manual mechanisms such as knobs or sliders, or automatedmechanisms such as motors controlled by a computer) that enablesmovement of the targeted sealant delivery catheter within the tissuespace such as the prostatic cavity. The targeted sealant deliverycatheter may be visualized within the tissue space using any appropriatevisualization method known in the art, in order to track and control themovement of the catheter to desired locations within the tissue space.The targeted delivery of sealant to specific portions of the internalsurface of the tissue space, such as the portions that are bleeding, canreduce the amount of sealant needed to achieve hemostasis in the tissuespace. Such targeted sealant delivery may be particularly well-suitedfor use following procedures that cause focal punctures or bleedingsites within the tissue space, such as the application of staples tospecific portions of the internal surface, or the focal injection (e.g.,through needles) of steam or other sources of energy to specificportions of the internal surface.

Optionally, any of the embodiments described herein may comprise one ormore light sources. The light source may promote direct visualization ofthe tissue space during use of the sealant delivery device. The lightsource may for example act as a waveguide. The light source may also beconfigured to cure photo-curable tissue sealants or adhesives. Forexample, some tissue adhesives such as cyanoacrylate-based sealants canbe cured using UV light, and the sealant delivery device may furthercomprise a UV light source to cure the sealant after delivery of thesealant into the resection cavity.

Optionally, any of the embodiments described herein may be adapted toheat or chill the tissue sealant. For example, some tissue sealants aretemperature-activated. The sealant delivery device may for example beadapted to deliver heated or chilled fluid to one or more of the distalor proximal balloons in order to activate or cure the tissue sealantprior to, during, or after delivery into the resection volume.

FIGS. 7A-7I show embodiments of a tissue debulking device which may beadapted as described in FIGS. 8A-8B for sealant delivery. FIGS. 7A-7Eshow the deployment and mechanism of action of a tissue debulking deviceor delivery probe used to deliver energy for prostatic tissue debulking.FIGS. 7F-7I show another embodiment of a tissue debulking device. Aplurality of carrier probes can be provided to allow the user to treatone or more of many tissues in a variety of ways. An elongate structuralelement having a working channel such as a shaft remains positioned inthe patient when a first carrier probe is exchanged with one or morecarrier probes. In many embodiments, the carrier probes can be rapidlyexchanged while a linkage remains fixedly attached to the elongateelement anchored to an internal structure of the patient. Each of thecarrier probes inserted into the patient can be identified based on atreatment plan, for example.

Referring to FIG. 7A, an exemplary prostatic tissue debulking device 10constructed in accordance with the principles of the present inventioncomprises a catheter assembly generally including a shaft 12 having adistal end 14 and a proximal end 16. The shaft 12 will typically be apolymeric extrusion including one, two, three, four, or more axiallumens extending from a hub 18 at the proximal end 16 to locations nearthe distal end 14. The shaft 12 will generally have a length in therange from 15 cm to 25 cm and a diameter in the range from 1 mm to 10mm, usually from 2 mm to 6 mm. The shaft will have sufficient columnstrength so that it may be introduced upwardly through the male urethra,as described in more detail below.

The shaft may include an energy source positioned in the energy deliveryregion 20, where the energy source can be any one of a number ofspecific components as discussed in more detail below. Distal to theenergy delivery region, an inflatable anchoring balloon 24 may bepositioned at or very close to the distal end 14 of the shaft. Theballoon may be connected through one of the axial lumens to a ballooninflation source 26 connected through the hub 18. In addition to theenergy source 22 and the balloon inflation source 26, the hub mayoptionally further include connections for an infusion/flushing source28, an aspiration (a vacuum) source 30, and/or an insufflation(pressurized CO₂ or other gas) source 32. In the exemplary embodiment,the infusion or flushing source 28 can be connected through an axiallumen (not shown) to one or more delivery ports 34 proximal to theballoon anchor 24 and distal to the energy delivery region 20. Theaspiration source 30 can be connected to a second port or opening 36,usually positioned proximally of the energy delivery region 20, whilethe insufflation source 32 can be connected to an additional port 38,also usually located proximal of the energy delivery region. It will beappreciated that the locations of the ports 34, 36, and 38 are notcritical, although certain positions may result in particular advantagesdescribed herein, and that the lumens and delivery means could beprovided by additional catheters, tubes, and the like, for exampleincluding coaxial sleeves, sheathes, and the like which could bepositioned over the shaft 12.

While the present embodiments are described with reference to the humanprostate, it is understood that they may be used to treat mammalprostates in general. Referring now to FIGS. 7B-7E, the prostatic tissuedebulking device 10 may be introduced through the male urethra U to aregion within the prostate P which is located immediately distal to thebladder B. The anatomy is shown in FIG. 7B. Once the catheter 10 hasbeen positioned so that the anchoring balloon 24 is located just distalof the bladder neck BN (FIG. 7C) the balloon can be inflated, preferablyto occupy substantially the entire interior of the bladder B, as shownin FIG. 7D. Once the anchoring balloon 24 is inflated, the position ofthe prostatic tissue debulking device 10 may be fixed and stabilizedwithin the urethra U so that the energy delivery region 20 is positionedwithin the prostate P. It will be appreciated that proper positioning ofthe energy delivery region 20 may depend only on the inflation of theanchoring balloon 24 within the bladder B. As the prostate is locatedimmediately proximal to the bladder neck BN, by spacing the distal endof the energy delivery region very close to the proximal end of theballoon, typically within the range from 0 mm to 5 mm, preferably from 1mm to 3 mm, the delivery region can be properly located. After theanchoring balloon 24 has been inflated, energy can be delivered into theprostate for debulking, as shown by the arrows in FIG. 7D. Once theenergy has been delivered for a time and over a desired surface region,the energy region can be stopped and the prostate will be debulked torelieve pressure on the urethra, as shown in FIG. 7E. At that time, aflushing fluid may be delivered through port 34 and aspirated into port36, as shown in FIG. 7E.

FIG. 7F shows rapid exchange of a carrier tube 380 when the linkage 430is coupled to the elongate element 310 anchored to a target location ofan organ. The elongate element 410 can be inserted or removed from thelinkage by the user. The elongate element 380 can be advanced intoopening 409 near connection structure 405 of the elongate tubularstructure 431.

The imaging probe 460 can be mounted on a second linkage and configuredto move with the nozzle of carrier 382, so as to image interaction ofthe energy stream from carrier 382 when tissue is treated. The images ofthe treatment may comprise axial images and sagittal images from theimaging probe 460. The linkage can be coupled to the controller orprocessor (or both) as described herein to move the imaging probe 460synchronously along the axis with the carrier 382 and nozzle of thecarrier, for example. The imaging probe 460 may comprise a trans-rectalultrasound probe and the carrier 482 may comprise a component of thetreatment probe 450 as described herein.

FIG. 7G shows alignment of the distal tip of the carrier 382 with theopening 409 of proximal end of the elongate tubular structure 431 toinsert the carrier tube 380 as in FIG. 7F.

FIG. 7H shows the carrier advanced toward a locking structure 406 on theproximal end of the linkage as in FIG. 7F. The locking structure 406 maybe sized to receive protrusion 404 so as to form a locked joint 402.

FIG. 7I shows the carrier tube 380 locked to the linkage 430 as in FIGS.7F and 7G. The protrusion 404 has been inserted into an opening oflocking structure 406 so as to form the locked joint. The joint can beunlocked by user manipulation.

Additional details regarding tissue resection or debulking devicessuitable for incorporation with embodiments are disclosed in U.S. Pat.No. 7,882,841, issued Feb. 8, 2011, entitled “MINIMALLY INVASIVE METHODSAND DEVICES FOR THE TREATMENT OF PROSTATE DISEASES”, U.S. Pat. No.9,232,959, entitled “MULTI FLUID TISSUE RESECTION METHODS AND DEVICES”,and International Application No. PCT/US2013/028441, filed on Feb. 28,2013, entitled “AUTOMATED IMAGE-GUIDED TISSUE RESECTION AND TREATMENT”,the full disclosures of which have been previously incorporated hereinby reference.

FIGS. 8A-8B show embodiments comprising the tissue debulking device ordelivery probe of FIGS. 7A-7I and a sealant applicator nozzle. Thesealant delivery device may, for example, be used to deliver ahemostatic agent or sealant into a cavity created by tissue resection bythe tissue debulking action of the device in the prostatic capsule.While the tissue debulking device of FIGS. 7A-7I is shown, it will beunderstood that many other existing tissue resection or tissue debulkingdevices may be adapted for sealant delivery

FIG. 8A shows a tissue debulking device 10 with attached sealantapplicator nozzle 812. The tissue debulking device 10 may be a deliveryprobe configured to deliver energy to a predetermined profile of theprostatic capsule 900. A processor may be operatively coupled to thedelivery probe and configured to control delivery of the sealant 701from the delivery probe to a predetermined profile of the tissue space.The sealant applicator nozzle 812 may be integral to the tissueresection device. The sealant applicator nozzle 812 may beinterchangeable with a tissue resection nozzle, for example, by rapidexchange of carrier probes as previously described herein. Alternativelyor in combination, the input fluid of the energy delivery probe may bealtered so as to provide for sealant delivery through the tissueresection nozzle. For example, the input fluid may be changed fromsaline to sealant after tissue resection. In some embodiments, thesaline used for tissue resection may be infused with a sealant prior to,during, or after tissue resection in order to promote hemostasis. Thesealant may be applied through the sealant applicator nozzle 812following tissue resection such that the sealant lines the cavity edge904 and promotes hemostasis. The sealant may for example be sprayed bythe tissue resection device. In the case of a tissue resection deviceusing water to ablate tissue, as previously described above, the sealantspray may be directed along the cavity edge 904 using the same angle anddepth profiles used during the tissue resection surgery. The water, orother energy source, may be delivered to the predetermined profile ofthe tissue volume at a first flow rate to resect the tissue and create aresection cavity 901. The sealant 701 may be delivered to the resectioncavity 901 at a second flow rate lower than the first flow rate. Thetissue resection device probe may also help to spread the sealant alongthe cavity edge 904 after delivery. The tissue resection device mayfurther comprise a distal balloon adjacent the distal end of thedelivery probe and a distal balloon inflation port at the proximal endof the delivery probe in fluid communication with the distal balloon.The distal balloon may be positioned adjacent to a distal opening of thetissue space so as to seal the bladder B upon inflation and close offthe tissue resection cavity 901, as shown in FIG. 8B. Delivery of thesealant may be confined to the resection cavity 901 by the inflation ofthe distal balloon. For sealants which are inactivated or do not bind totissue in liquids, the liquids and resected tissues may first beaspirated from the resection cavity 901 through an aspiration port ofthe sealant delivery device. The prostatic capsule 900 may then beinsufflated by the infusion of a gas or other fluid, for example, carbondioxide (CO₂), through an insufflation port to provide a dry volume inwhich to apply the sealant. The creation of a dry volume inside theresection cavity 901 may further promote the spraying action of thesealant and may improve the reach of the sealant into the cavity edge904. Alternatively, a dry sealant may be delivered in any of theembodiments described herein which, upon delivery to the resectioncavity 901, mixes with the liquid inside the resection cavity 901 andforms a sealant agent. Alternatively, the prostatic capsule 900 may beinsufflated by the introduction of the sealant fluid. Any of theembodiments described herein may be configured to aspirate one or moreof tissues or fluids from the cavity, for example through an aspirationport in the catheter or delivery probe. Any of the embodiments describedherein may be configured to insufflate the cavity, for example through agas infusion port in the catheter or delivery probe.

Alternatively or in combination, the sealant delivery device may beconfigured such that any of the catheter embodiments described hereinmay replace the sealant applicator nozzle shown. The tissue resectionnozzle may for example be rapidly exchanged with a catheter comprisingone or more balloons to deliver the sealant to the cavity as describedherein. Alternatively or in combination, the sealant applicator nozzlemay deliver sealant to the cavity as described then be exchanged with acatheter comprising one or more expandable members, for example aproximal balloon, to compress and/or move the sealant along the cavitywalls as described herein.

FIG. 9 shows a flowchart of a method of providing hemostasis within atissue cavity.

At Step 901, a sealant delivery device may be provided. The sealantdelivery device may, for example, be any of the embodiments describedherein.

At Step 902, the sealant delivery device may be advanced through aproximal opening of the tissue volume into a cavity defined by aninternal surface of a bleeding tissue volume.

At Step 903, the sealant delivery device may be positioned such that adistal balloon is adjacent a distal opening of the tissue volume. Step903 may further comprise a substep, Step 903A, in which a proximalballoon of the sealant delivery device is positioned at least partiallywithin the cavity.

At Step 904, the distal balloon may be expanded to seal the distalopening. Sealing the distal opening may comprise conforming the expandeddistal balloon to a shape of the bladder neck and/or cavity space.

At Step 905, the fluids may optionally be removed from the tissuecavity. Fluid removal may comprise one or more substeps. At Step 905A,the fluids may be aspirated from the tissue cavity. At Step 905B, thecavity may be insufflated with the sealant fluid. At Step 905C, thecavity may be insufflated with a gas or other fluid.

At Step 906, a hemostatic sealant is provided to the cavity. Step 906may comprise one or more substeps. For example, at Step 906A, thesealant may be delivered from a catheter of the sealant delivery deviceinto the cavity. At Step 906B, the sealant may be delivered from, ordelivered by in the form of a sealant scaffold for example, the proximalballoon into the tissue cavity. At Step 906C, the proximal balloon maybe expanded to compress the sealant against the internal surface of thecavity, for example the cavity edge. At Step 906D, the proximal balloonmay be expanded to seal the proximal opening of the tissue cavity. AtStep 906E, the proximal balloon may be moved along a longitudinal axisof the sealant delivery catheter to spread the sealant over the internalsurface of the tissue volume. At Step 906F, the excess sealant may beremoved from the cavity.

At Step 907, the distal balloon may be collapsed. Step 907 may furthercomprise the substep Step 907A in which the proximal balloon iscollapsed.

At Step 908, the sealant delivery device may be removed from the cavity.

Although the steps above show a method of providing hemostasis usingsealant delivery device in accordance with embodiments, a person ofordinary skill in the art will recognize many variations based on theteaching described herein. The steps may be completed in a differentorder. Steps may be added or deleted. Some of the steps may comprisesub-steps. Many of the steps may be repeated to provide hemostasis in ableeding closed tissue volume.

In an exemplary embodiment of the method described by FIG. 9, thesealant delivery device may comprise the sealant delivery device ofFIGS. 1A-1C. The tissue volume may comprise a prostatic capsule of theprostate, wherein the proximal opening comprises an opening to theurethra and the distal opening comprises a bladder neck between theprostate and the bladder. The cavity may comprise a resection cavityleft after tissue debulking. The sealant delivery device may be advancedthrough the urethra into the resection cavity and positioned such thatthe distal balloon resides within the bladder adjacent the bladder neck.Expansion of the distal balloon may seal the cavity by sealing thebladder neck. The proximal balloon may be inflated prior to, during, orafter sealant delivery. The sealant may be delivered into the cavitythrough the catheter. Expansion of the proximal balloon may compress thesealant into the internal surface of the cavity comprising the cavityedge. The proximal and distal balloons may remain inflated untilhemostasis has occurred, at which point the balloons may be collapsedand the sealant delivery device removed from the cavity.

In another exemplary embodiment of the method described by FIG. 9, thesealant delivery device may comprise a tissue debulking device such asthe sealant delivery device of FIGS. 8A-8B. The sealant delivery devicemay comprise an energy delivery probe, for example a tissue debulkingdevice, with a sealant delivery nozzle. The tissue volume may comprise aprostatic capsule of the prostate, wherein the proximal openingcomprises an opening to the urethra and the distal opening comprises abladder neck between the prostate and the bladder. The sealant deliverydevice may be advanced into the tissue volume through the urethra intothe prostatic capsule and positioned such that the distal balloonresides within the bladder adjacent the bladder neck. Energy may bedelivered from the energy delivery probe to a predetermined profile ofthe tissue volume at a first flow rate to debulk the tissue volume andthereby create the resection cavity. The distal balloon may then beexpanded to seal the resection cavity and fluids may be aspirated fromthe cavity. The cavity may then be insufflated with a gas, for exampleCO₂. The sealant delivery device may then deliver the sealant into theclosed cavity. The distal balloon may be collapsed once hemostasis hasbegun for removal of the sealant delivery device.

While specific mention has been made herein to delivery of a sealant byone or more of the proximal balloon, catheter, or delivery probe, thedistal balloon may also be adapted to deliver sealant into the tissuespace. For example, a proximal portion of the distal balloon, whichforms a seal about the tissue space at the distal opening of the space,may be configured to deliver sealant into the tissue cavity. Theproximal portion of the distal balloon may for example comprise pores orholes through which sealant may be delivered, as described herein. Inany of the embodiments described herein, one or more of the catheter,delivery probe, proximal balloon, or distal balloon may configured toapply a sealant to the space enclosed within the tissue. For example, insome embodiments, the distal balloon and the catheter are configured todeliver sealant. In some embodiments, the distal balloon and theproximal balloon are configured to deliver sealant. In some embodiments,the distal balloon and the delivery probe are configured to deliversealant. In some embodiments, only the distal balloon is configured todeliver sealant. In some embodiments, only the proximal balloon isconfigured to deliver the sealant. It will be understood thatembodiments of the sealant delivery device may take on manyconfigurations, which may include one or more balloons, one or morecatheter, or one or more delivery probe.

While specific mention has been made herein to uniform delivery of ahemostatic sealant to a tissue enclosing a space, for example aresection cavity, delivery of the sealant may also be targeted tospecific locations within said tissue space. The embodiments describedherein may be configured to deliver sealant to specific locations withinthe tissue space. In many embodiments, the sealant delivery device maycomprise a separate small lumen catheter which may be used to directsealant to a certain part of the tissue. For example, many tissueresection devices developed for use in the prostate may leave behindfocal lesions or injuries, particularly in cases where needles are usedto puncture the tissue space, which could be treated by focal deliveryof sealant. The sealant delivery device may be brought under directvisualization to help direct it to the site of bleeding. The puncturesmay be sealed with focal delivery of sealant applied by the catheter.Targeting the delivery of sealant may minimize the sealant required toestablish hemostasis and may prevent or minimize any side effects whichmay occur due to over-use of the sealant. Visualization of bleeding andtargeted delivery of sealant may be used with any of the embodimentsdescribed herein to minimize the amount of sealant required and promotehemostasis.

FIGS. 10A-10G show embodiments of a minimally invasive sealant deliverydevice comprising a scope and related methods. The sealant deliverydevice may, for example, be used to deliver a hemostatic agent orsealant into a cavity created by tissue resection in the prostaticcapsule 900.

The sealant delivery device may comprise one or more of a rigid scope, aflexible scope, or a telescopic scope. The scope may be a cystoscope, aresectoscope, a ureteroscope, or the like. The scope can be configuredin many ways and may be used to visualize and/or guide sealant deliveryinto the cavity. The scope can be positioned in order to view thedelivery of the sealant when placed from the delivery device and atother times during the tissue sealing procedure. The outer sheath asdisclosed herein can be configured for use with a resectoscope or otherdevice used for surgery as described in the applications incorporatedherein by reference. The scope may comprise an outer shaft over whichthe sheath is placed, and the sheath may have a length sized smallerthan the length of the shaft in order to allow visualization when thesheath is placed over scope. In many embodiments, the outer sheathcomprises a length within a range from about 15 to 30 mm in order toallow visualization of the treatment size with the scope when the sheathis placed over the scope.

The sealant delivery device may be delivered through the urethra suchthat the distal end of the scope is in the bladder or tissue resectioncavity, for example, near the bladder neck. The sealant delivery devicemay be stationary in the cavity during at least a portion of the sealingprocedure. The sealant delivery device may be moved within the cavity inorder to direct sealant delivery to locations of bleeding within thetissue resection cavity, for example near the bladder neck. The sealantdelivery device may further comprise an injection port fluidly coupledvia a working channel to the distal end of the sealant delivery device.A syringe may be used to inject a sealant at the injection port asshown.

FIG. 10A shows delivery of a sealant 701 into the resection cavity 901of the prostatic capsule 900. The scope 600 may be advanced through theurethra into the cavity via the proximal opening 902. The sealant 701may be infused into the scope 600 through a sealant injection port 601located near the proximal end of the scope 600. The sealant 701 may bedelivered to the resection cavity 901 via a sealant delivery port or theopening of the working channel of the scope 600 (not shown) located nearthe distal end of the scope 600 residing inside the prostatic capsule900.

The scope 600 may further comprise an optional catheter sleeve similarto any of the catheter embodiments described herein. The catheter may bea customizable sleeve configured to be deployed inside or outside thescope 600 to enhance sealant delivery. FIG. 10B shows an embodiment of acatheter sleeve comprising a modified Foley catheter. The catheter maycomprise a distal balloon and a proximal balloon and may be deliveredthrough the urethra such that distal balloon and proximal balloon arepartially or fully inserted into the bladder B and prostatic capsule900, respectively. The catheter may be sized and shaped to closely fitwithin the proximal opening 902 of the prostatic capsule 900 to theurethra, such that when the catheter is advanced into the prostaticcapsule 900, the catheter body can substantially seal off the proximalopening 902 to inhibit leakage of the sealant into the urethra. Thesealant can be applied to the resected tissue near the bladder neck BNin order to inhibit bleeding, and the sealant can be applied without aballoon, for example.

The catheter may further comprise one or more of an irrigation port, adrainage port, an inflation port for the distal bladder balloon, or aninflation port for the proximal prostatic balloon as described herein.The inflation ports may be fluidly coupled to the balloons and used toinflate the distal and proximal balloons, respectively. The irrigationand drainage ports may be used to introduce fluids, such as saline andmedications, into the bladder and remove fluids, such as urine, from thebladder, respectively, via one or more ports at the distal end of thecatheter. The prostatic capsule 900 may be sealed off from the bladderwhile still allowing for the passage of fluids to and from the bladderwhen the distal balloon in inflated using the inflation port for thedistal balloon.

FIG. 10B shows the resection cavity 901 filled with the sealant 701after delivery through the working channel of the scope as describedherein. The distal balloon 808 may be inflated prior to, during, orafter delivery of the sealant to the cavity. The distal balloon 808 maybe inflated so as to completely seal off the bladder B from theprostatic capsule 900 at the distal opening 903 of the prostatic capsule900 comprising the bladder neck BN, such that only the resection cavity901 receives the sealant. Alternatively, the distal balloon 808 may beinflated so as to partially, or nearly completely, seal off the bladderB from the prostatic capsule 900. For example, the distal balloon 808may be inflated so as to leave a small space between the bladder neck BNand the distal balloon 808. This may allow a small amount of sealant toreach the bladder neck itself, as described herein. This may beadvantageous in situations where the bladder neck area is the source ofbleeding, as the bladder neck common location of bleeding followingtissue resection in the prostatic capsule 900. The catheter body mayseal off the proximal opening 902 while the catheter is positioned withthe cavity, such that the sealant does not enter the urethra.

The balloons can be filled and the sealant applied in any order orrepeatedly, for example. The distal balloon 808 may be positionedadjacent to a distal opening 903 of the tissue space so as to seal thebladder upon inflation and isolate the tissue resection cavity 901 inorder to apply sealant to the tissue of the resection cavity 901. Theproximal balloon 806 may be positioned so as to reside within theresection cavity 901 of the prostatic capsule 900. The proximal balloon806 can be inflated in order to urge tissue sealant toward the tissue ofthe resection cavity 901. The distal balloon 808 can be inflated firstin order to isolate the tissue resection cavity 901, and the proximalballoon 806 inflated after the distal balloon 808 in order to allowreduced amounts of sealant to be used. The tissue sealant can bedelivered before or after (or both) inflation of the proximal balloon806.

The proximal balloon 806 may be inflated after delivery of the sealant701 to an expanded configuration. Alternatively, the proximal balloon806 may be inflated prior to or during delivery of the sealant in orderto reduce the amount of sealant need to coat the edge of the cavity. Theproximal balloon 806 may be inflated in order to compress the sealantagainst an internal surface of the cavity, for example the cavity edge904 at the periphery of the resection cavity 901, thus ensuring deliveryto the entire tissue area of the cavity edge 904. The proximal balloon806 may be an actuatable balloon, similar to the example shown in FIGS.6A-6C for example, which may be actuated to spread sealant within thecavity. The catheter may be left in the patient with the proximalballoon 806 inflated for an amount of time to ensure hemostasis hasoccurred. The amount of time for hemostasis may depend on the sealantused and may range from minutes to hours to overnight. The sealantdelivery device may be removed from the patient after the sealant hassealed.

Although reference is made to balloons, any expandable member can beused similarly to the balloons as described herein, such as expandablewires, meshes, coverings, and actuators and combinations thereof.

FIG. 10C shows delivery of the sealant 701 into the resection cavity 901of the prostatic capsule 900 using a stylet 603 or other plunger, forexample. In at least some instances, the working channel or sealantinjection pathway of the sealant deliver device may comprise a volumelarger than the available volume of sealant or the volume of sealantnecessary to seal the bleeding tissue. In many cases, sealants may beprovided in small packages by manufacturers, for example about 5 ml toabout 10 ml per package. Therefore, there may be a benefit to themethods and apparatus described herein that are capable of deliveringsmall volumes without costly wastage of sealant. For example, a styletmay be used after injecting sealant into the working channel via theinjection port 601. The stylet 603 may be loaded into the injection port601 and pushed towards the distal end of the sealant delivery device soas to push at least a portion of the sealant residing in the device outinto the resection cavity 901. The stylet 603 may be sized and shaped tofit the working channel such that little or no sealant remains withinthe device when the stylet 603 is advanced completely through theworking channel to the distal end of the device.

FIGS. 10D-10F show alternative embodiments of a sealant delivery device.The sealant delivery device shown in FIG. 10A may further comprise acannula or tube 604. In at least some instances, the internal geometryof the working channel may be tortuous or not round which may limitdelivery of the sealant into the resection cavity 901. The cannula 604may be inserted into the working channel of the scope through theinjection port so as to provide a smooth, round sealant deliverypathway. The cannula 604 may be sized and shaped to fit within theworking channel of the scope. FIG. 10D shows an exemplary cannula 604which may have proximal and distal ends 6041 and 6042 corresponding tothe proximal and distal ends of the working channel of the scope,respectively. Sealant may be injected with a syringe 602 into theproximal end 6041 of the cannula 604 and delivered to the cavity by thedistal end 6042 which resides at the distal end of the scope inside thecavity as described herein. An optional stylet may be used afterinjecting sealant into the cannula 604 to plunge the sealant out of thecannula 604, for example, if there is more dead space than ideal orwhere amounts of sealant are limited, for example as show in FIG. 10E.FIG. 10F shows the sealant delivery device of FIG. 10A furthercomprising a cannula and stylet 603 so as to provide more completedelivery of sealant to the resection cavity 901, for example insituations where the volume of the working channel or cannula 604 islarger than the available or cost-effective volume of sealant.

FIG. 10G shows an alternative embodiment of a catheter sleeve. Thecatheter may comprise a distal balloon 808 and may be delivered throughthe urethra such that distal balloon 808 is fully inserted into thebladder B. The catheter may be sized and shaped to the closely fitwithin the proximal opening 902 of the prostatic capsule 900 to theurethra, such that when the catheter is advanced into the prostaticcapsule 900, the catheter body substantially seals off the opening. Thedistal balloon 808 may be positioned adjacent to a distal opening 903 ofthe tissue space so as to seal the bladder B upon inflation and closeoff the tissue resection cavity 901 as shown. Alternatively, the distalballoon 808 may be positioned so as to reside within the resectioncavity 901 of the prostatic capsule 900 and may compress the sealanttoward the resected tissue.

The catheter may further comprise one or more of an irrigation port, adrainage port, or an inflation port for the distal bladder balloon, asdescribed herein (not shown). The inflation port may be fluidly coupledto the distal balloon 808 and used to inflate the balloon. Theirrigation and drainage ports may be used as described herein. Theprostatic capsule 900 may be sealed off from the bladder B while stillallowing for the passage of fluids to and from the bladder B when thedistal balloon 808 in inflated using the inflation port for the distalballoon.

The resection cavity 901 may be filled with the sealant after deliverythrough the working channel of the scope as described herein. The distalballoon 808 may be inflated prior to, during, or after delivery of thesealant to the cavity. The distal balloon 808 may be inflated so as tocompletely seal off the bladder B from the prostatic capsule 900 at thedistal opening 903 of the prostatic capsule 900 comprising the bladderneck BN, such that only the resection cavity 901 receives the sealant.Alternatively, the distal balloon 808 may be inflated so as topartially, or nearly completely, seal off the bladder B from theprostatic capsule 900. For example, the distal balloon 808 may beinflated so as to leave a small space between the bladder neck BN andthe distal balloon 808 as described herein. The catheter body may sealoff the proximal opening 902 while the catheter is positioned within thecavity, such that the sealant does not enter the urethra.

The catheter may be left in the patient with the proximal ballooninflated for an amount of time to ensure hemostasis has occurred. Theamount of time for hemostasis may depend on the sealant used and mayrange from minutes to hours to overnight. The sealant delivery devicemay be removed from the patient after the sealant has sealed.

FIGS. 11A-11D show an embodiments of a minimally invasive sealantdelivery device and related methods of use. The sealant delivery devicemay be used to deliver a hemostatic agent or sealant into a cavitycreated by tissue resection in the prostatic capsule, for example. Thesealant delivery device may comprise a catheter comprising a distalballoon and may be delivered through the urethra such that distalballoon is positioned in the urethra near the external sphincter duringsealant delivery into the resection cavity. The distal balloon may befully inserted into the prostatic capsule after sealant delivery so asto reside within the resection cavity. The catheter may be sized andshaped to the closely fit within the proximal opening of the prostaticcapsule to the urethra, such that when the catheter is advanced into theprostatic capsule, the catheter body substantially seals off theproximal opening.

In some embodiments, the catheter may comprise a second balloon, forexample a proximal balloon located proximal to the distal balloon. Insuch embodiments, the catheter may be inserted into the prostaticcapsule after sealant delivery such that the distal balloon and proximalballoon are fully inserted into the bladder and prostatic capsule,respectively, as described herein. The distal balloon may be positionedadjacent to a distal opening of the tissue space so as to seal thebladder upon inflation and close off the tissue resection cavity. Theproximal balloon may be positioned so as to reside within the resectioncavity of the prostatic capsule and compress the sealant to the cavityedge upon inflation.

The catheter may further comprise one or more of an irrigation port, adrainage port, an inflation port for the distal balloon, or a cannula.The inflation port may be fluidly coupled to the balloon and used toinflate the distal balloon. The irrigation and drainage ports may beused as previously described herein. The cannula may be inserted intothe drainage port of the catheter so as to provide a smooth, roundsealant delivery pathway as described herein.

FIG. 11A shows initial deployment of the sealant delivery device intothe resection cavity 901 of the prostatic capsule 900. The device may beadvanced through the urethra into the cavity via the proximal opening902. The distal balloon may be positioned in the urethra such that thedistal end of the catheter is near the proximal opening 902 of thetissue volume. The cannula 604 may be positioned within the cathetersuch that the distal end of the cannula 604 extends beyond the distalend of the catheter into the cavity for sealant delivery. The cannula604 may be sized and shaped to fit within the drainage port. The cannula604 may be sized and shaped to provide a sealant injection pathwaycomprising a smaller internal volume than the drainage port and lumen ofthe catheter. For example, in many cases sealants are provided in smallpackages by manufacturers, for example about 5 ml to about 10 ml perpackage, while a traditional Foley catheter comprises an internal volumeof about 20 ml. By providing an appropriately shaped and sized cannula,the working internal volume of the sealant delivery pathway may reducethe amount of sealant used and prevent waste.

The delivery devices as described herein may comprise an internal volumeof no more than about 5 ml along the sealant delivery channel betweenthe proximal and distal ends, for example, an internal volume within arange from about 0.5 ml to about 5 ml.

FIG. 11B shows delivery of a sealant 701 into the resection cavity 901of the prostatic capsule 900. Sealant may be injected with a syringe 602into the proximal end of the cannula 604 and delivered to the cavity bythe distal end of the cannula 604 residing inside the prostatic capsule900. FIG. 11C shows the use of an optional stylet 603 to plunge thesealant out of the cannula 604 stylet so as to ensure complete deliveryof sealant to the resection cavity 901 as described herein.Alternatively, the stylet 603 may be sized and shaped to fit within thedrainage port 802 such that the cannula 604 is optional and the stylet603 may push sealant out of the catheter without the use of a cannula604 therebetween. A stylet 603 may be applied to any of the embodimentsdescribed herein with or without a cannula. The stylet 603 may be loadedinto the cannula 604 or drainage port and pushed towards the distal endof the sealant delivery device so as to push at least a portion of thesealant residing in the device out into the resection cavity 901.

FIG. 11D shows the resection cavity 901 filled with the sealant 701after delivery through the drainage port or cannula. The drainagechannel extending between the drainage port 802 and bladder port 809 canbe substantially clear of tissue sealant in order to allow drainagethrough the catheter, although some residual sealant may remain in thedrainage channel when urine is passed through the channel used to tissuesealant. Following delivery of sealant to the cavity, the sealantdelivery device may be advanced into the prostatic capsule 900. Thedistal balloon 808 may reside within the resection cavity 901 and may beinflated in order to compress the sealant against an internal surface ofthe cavity, for example the cavity edge 904 at the periphery of theresection cavity 901, thus ensuring delivery to the most of tissue areaof the cavity edge 904, and in some instances the entire cavity edge904. The catheter may be left in the patient with the distal balloon 808inflated for an amount of time to ensure hemostasis has occurred. Theamount of time for hemostasis may depend on the sealant used and mayrange from minutes to hours to overnight or longer. The sealant deliverydevice may be removed from the patient after the sealant has sealed, andresidual sealant may remain in the drainage port 802 subsequent toremoval.

In any of the embodiments described herein, insertion of the sealantdelivery device and/or delivery of sealant to the cavity may be guidedby transrectal ultrasound (TRUS) or other imaging modalities for visualguidance. TRUS may be used to guide actuation of the catheter duringsealant delivery, for example by retracting or advancing the catheterwithin the cavity by mechanical or manual means. The delivery device mayfor example deliver sealant to the distal opening 903 of the resectioncavity and move proximally as the sealant is injected so as to promoteeven and homogeneous sealant delivery

FIGS. 12A-12B show another an embodiment and related methods of aminimally invasive sealant delivery device. The sealant delivery devicemay, for example, be used to deliver a hemostatic agent or sealant intoa cavity created by tissue resection in the prostatic capsule. Thesealant delivery device may comprise a catheter comprising a distalballoon and may be delivered through the urethra such that distalballoon is fully inserted into the bladder. The distal balloon may bepositioned adjacent to a distal opening of the tissue space so as toseal the bladder upon inflation and close off the tissue resectioncavity.

The catheter may further comprise one or more of an irrigation port, adrainage port, an inflation port for the distal bladder balloon, or asealant infusion port as previously described herein. The inflation portmay be fluidly coupled to the balloon and used to inflate the distalballoon. The sealant infusion port may be used to deliver sealant to theresection cavity prior to, during, or after inflation of the distalballoon.

FIG. 12A shows delivery of a sealant 701 into the resection cavity 901of the prostatic capsule 900. The catheter may be advanced through theurethra into the cavity via the proximal opening 902. The sealant 701may be infused into the catheter through a sealant infusion port 801located near the proximal end of the catheter and positioned distallywith respect to the distal balloon 808. The sealant may be delivered tothe resection cavity 901 via a sealant delivery port 807 located on thecatheter residing inside the prostatic capsule 900. The sealant deliveryport 807 may be located near the distal balloon 808. The sealantdelivery port may be about 0.1 mm to about 70 mm away from the distalballoon, for example about 0.1 mm to about 60 mm. The sealant deliveryport may have a maximum dimension across, for example a diameter, withina range from about 15 to 30 mm. Although only one sealant delivery portis shown, it will be understood that the catheter may comprise aplurality of sealant delivery ports. The distal balloon 808 may beinflated so as to completely seal off the bladder B from the prostaticcapsule 900 at the bladder neck BN as previously described herein.

FIG. 12B shows the resection cavity 901 filled with the sealant 701after delivery. Inflow of sealant through the sealant delivery port 807may result in a positive pressure within the resection cavity 901. Thepositive pressure may ensure even distribution of the sealant to thecavity edge 904 without the use of an additional as described herein.The positive pressure may also be useful in opening a cavity which hascollapsed following tissue resection. The catheter may be left in thepatient with said positive pressure for an amount of time to ensurehemostasis has occurred. The amount of time for hemostasis may depend onthe sealant used and may range from minutes to hours to overnight.

FIGS. 13A-13D show yet another embodiment of a minimally invasivesealant delivery device and related methods. The device may besubstantially similar to the device of FIGS. 11A-11D. The sealantdelivery device may, for example, be used to deliver a hemostatic agentor sealant into a cavity created by tissue resection in the prostaticcapsule. The sealant delivery device may comprise a catheter comprisinga distal balloon and may be delivered through the urethra such thatdistal balloon is positioned in the urethra near the external sphincterduring sealant delivery into the resection cavity. The distal balloonmay be fully inserted into the prostatic capsule after sealant deliveryso as to be positioned adjacent to a distal opening of the tissue spaceso as to seal the bladder upon inflation and close off the tissueresection cavity. The catheter may be sized and shaped to the closelyfit within the proximal opening of the prostatic capsule to the urethra,such that when the catheter is advanced into the prostatic capsule, thecatheter body substantially seals off the proximal opening.

In some embodiments, the catheter may comprise a second balloon, forexample, a proximal balloon located proximal to the distal balloon. Insuch embodiments, the catheter may be inserted into the prostaticcapsule after sealant delivery such that the distal balloon and proximalballoon are fully inserted into the bladder and prostatic capsule,respectively, as described herein. The proximal balloon may bepositioned so as to reside within the resection cavity of the prostaticcapsule and compress the sealant to the cavity edge upon inflation.

The catheter may further comprise one or more of an irrigation port, adrainage port, an inflation port for the distal balloon, or a cannula.The inflation port may be fluidly coupled to the balloon and used toinflate the distal balloon. The irrigation and drainage ports may beused as previously described herein. The cannula may be inserted intothe drainage port of the catheter so as to provide a smooth, roundsealant delivery pathway as described herein.

FIG. 13A shows initial deployment of the sealant delivery device intothe resection cavity 901 of the prostatic capsule 900. The device may beadvanced through the urethra into the cavity via the proximal opening902. The distal balloon 808 may be positioned in the urethra such thatthe distal end of the catheter is near the proximal opening 902 of thetissue volume. The cannula 604 may be positioned within the cathetersuch that the distal end of the cannula 604 extends beyond the distalend of the catheter into the cavity for sealant delivery. The cannula604 may be sized and shaped to fit within the drainage port 802. Thecannula 604 may be sized and shaped to provide a sealant injectionpathway comprising a smaller internal volume than the drainage port andlumen of the catheter to prevent waste as described herein.

FIG. 13B shows delivery of a sealant 701 into the resection cavity 901of the prostatic capsule 900. Sealant 701 may be injected with a syringe602 into the proximal end of the cannula 604 and delivered to the cavityby the distal end of the cannula 604 residing inside the prostaticcapsule 900. FIG. 13C shows the use of an optional stylet 603 to plungethe sealant 701 out of the cannula stylet so as to ensure completedelivery of sealant to the resection cavity 901 as described herein.Alternatively, the stylet 603 may be sized and shaped to fit within thedrainage port 802 such that the cannula is optional as described herein.

FIG. 13D shows the resection cavity 901 filled with the sealant 701after delivery through the drainage port or cannula. Following deliveryof sealant to the cavity, the sealant delivery device may be advancedinto the prostatic capsule 900. The distal balloon 808 may be inflatedso as to completely seal off the bladder B from the prostatic capsule900 at the distal opening 903 of the prostatic capsule 900 comprisingthe bladder neck BN, such that only the resection cavity 901 receivesthe sealant 701. Alternatively, the distal balloon 808 may be inflatedso as to partially, or nearly completely, seal off the bladder B fromthe prostatic capsule 900. For example, the distal balloon 808 may beinflated so as to leave a small space between the bladder neck BN andthe distal balloon 808 as described herein. The catheter body may sealoff the proximal opening 902 while the catheter is positioned within thecavity, such that the sealant does not enter the urethra. The cathetermay be left in the patient with the distal balloon 808 inflated for anamount of time to ensure hemostasis has occurred. The amount of time forhemostasis may depend on the sealant used and may range from minutes tohours to overnight. The sealant delivery device may be removed from thepatient after the sealant has sealed.

FIG. 14 shows a flowchart of a method 1400 of providing hemostasiswithin a tissue cavity.

At Step 1401, a sealant delivery device may be provided. The sealantdelivery device may, for example, be any of the embodiments describedherein.

At Step 1402, the sealant delivery device may be advanced through aproximal opening of the tissue volume into a cavity defined by aninternal surface of a bleeding tissue volume.

At Step 1403, the sealant delivery device may be positioned such that adistal balloon is adjacent a distal opening of the tissue volume.

At Step 1404, a hemostatic sealant may be provided to the cavity. Step1404 may comprise one or more substeps. For example, at Step 1404A, thesealant may be delivered from a catheter of the sealant delivery deviceinto the cavity. At Step 1404B, the sealant may be delivered from ascope into the tissue cavity.

At Step 1405, the distal balloon may be expanded. The distal balloon maybe positioned such that inflation causes the balloon to seal the distalopening, for example at the bladder neck (Step 1405A). The distalballoon may be positioned such that inflation causes the balloon tocompress sealant against an internal surface or edge of the cavity, forexample within the prostatic resection cavity (Step 1405B).

At Step 1406, the distal balloon may be collapsed.

At Step 1407, the sealant delivery device may be removed from thecavity.

Although the steps above show a method of providing hemostasis usingsealant delivery device in accordance with embodiments, a person ofordinary skill in the art will recognize many variations based on theteaching described herein. The steps may be completed in a differentorder. Steps may be added or deleted. Some of the steps may comprisesub-steps. Many of the steps may be repeated to provide hemostasis in ableeding closed tissue volume. Each of the delivery devices as describedherein can be used in accordance with the method 1400.

In an exemplary embodiment of the method described by FIG. 14, thesealant delivery device may comprise the sealant delivery device ofFIGS. 13A-13D. The tissue volume may comprise a prostatic capsule of theprostate, wherein the proximal opening comprises an opening to theurethra and the distal opening comprises a bladder neck between theprostate and the bladder. The cavity may comprise a resection cavityleft after tissue debulking. The sealant delivery device may be advancedthrough the urethra into the resection cavity and positioned such thatthe distal balloon lies in the urethra near the external sphincterduring sealant delivery into the resection cavity. The distal balloonmay be positioned in the urethra such that the distal end of thecatheter is near the proximal opening of the tissue volume. The cannulamay be positioned within the catheter such that the distal end of thecannula extends beyond the distal end of the catheter into the cavityfor sealant delivery. The sealant may be delivered into the cavitythrough the cannula. The sealant delivery device may then be advancedinto the prostatic capsule such that the distal balloon resides withinthe bladder adjacent the bladder neck. Expansion of the distal balloonmay seal the cavity by sealing the bladder neck. The distal balloon mayremain inflated until hemostasis has occurred, at which point theballoon may be collapsed and the sealant delivery device removed fromthe cavity.

While many of the embodiments described herein comprise one or moreballoons, it will be understood that any of the sealant delivery devicesdescribed herein may not comprise a balloon. For example, sealant may bedelivered by a catheter comprising a sealant delivery port into theresection cavity. Sealing of the tissue may be accomplished without theuse of a distal balloon to seal of the bladder or compress the bladderneck. Sealing of the tissue may occur without the use of a distal orproximal balloon to compress or spread the sealant into and along thecavity edge.

Optionally or in combination with one or more of any of the embodimentsdescribed herein, the sealant used may be combined with one or moretherapeutic agents. The therapeutic agent may comprise one or more ofpain relievers, analgesics, anesthetics, chemotherapeutics, drugs totreat cancer, radiopharmaceuticals, antibiotics, hemostatic and sealingagents, or vasoconstrictors. The therapeutic agents can be combined inmany ways to improve results, and may comprise a combination of two ormore therapeutic agents as disclosed herein.

The therapeutic agent may be delivered to a target region in many ways,and the target region may comprise as a cavity formed in resected tissueas described herein.

Pain relievers may be delivered to a region or optionally combined witha sealant in accordance with one or more of any the embodimentsdescribed herein. The pain reliever may comprise one or more ofacetaminophen, acetylsalicylic acid, benzocaine, bromfenac,buprenorphine, butorphanol, capsaicin, celecoxib, codeine, dexibuprofen,dibucaine, diclofenac, diflunisal, etodolac, fenoprofen, flufenamicacid, flurbiprofen, hydrocodone dryomorphone, ibuprofen, indomethacin,ketoprofen, ketorolac, levorphanol, lidocaine, lomoxicam, loxoprofen,meclofenamate, mefenamic acid, meloxicam, meperidine, methadone,menthol, morphine, nabumetone, nalbuphine, naproxen, oxaprozin,oxycodone, oxymorphone, pentazocine, phenylbutazone, piroxicam,prilocaine, propoxyphene, salsalate, sulindac, tapentadol, tenoxicam,tolfenamic acid, tolmetin, or tramadol, for example.

Chemotherapeutic agents and other drugs to treat cancer may be deliveredto the region and optionally combined with a sealant as describedherein. The chemotherapeutic agent may comprise one or more ofabiraterone acetate, ABVD, ABVE, ABVE-PC, AC, AC-T, ADE, ado-trastuzumabemtansine, afatinib dimaleate, aldesleukin, alectinib, alemtuzumab,aminolevulinic acid, anastrozole, aprepitant, arsenic trioxide,asparaginase Erwinia chrysanthemi, atezolizumab, axitinib, azacitidine,BEACOPP, belinostat, bendamustine hydrochloride, BEP, bevacizumab,bexarotene, bicalutamide, bleomycin, blinatumomab, bortezomib,bosutinib, brentuximab vedotin, BuMel, busulfan, cabazitaxel,cabozantinib-s-malate, CAF, capecitabine, CAPDX, carboplatin,carfilzomib, carmustine, carmustine implant, CEM, ceritinib, cetuximab,chlorambucil, chlorambucil-prednisone, CHOP, cisplatin, clofarabine,CMF, cobimetinib, COPDAC, COPP, COPP-ABV, crizotinib, CVP,cyclophosphamide, cytarabine, cytarabine liposome, dabrafenib,dacarbazine, dactinomycin, daratumumab, dasatinib, daunorubicinhydrochloride, decitabine, defibrotide sodium, degarelix, denileukindiftitox, denosumab, dexamethasone, dexrazoxane hydrochloride,dinutuximab, docetaxel, doxorubicin hydrochloride, doxorubicinhydrochloride liposome, elotuzumab, eltrombopag olamine, enzalutamide,epirubicin hydrochloride, EPOCH, eribulin mesylate, erlotinibhydrochloride, etoposide, etoposide phosphate, everolimus, filgrastim,fludarabine phosphate, fluorouracil injection, fluorouracil—topical,flutamide, FOLFIRI, FOLFIRI-bevacizumab, FOLFIRI-cetuximab, FOLFIRINOX,FOLFOX, FU-LV, fulvestrant, gefitinib, gemcitabine hydrochloride,gemcitabine-cisplatin, gemcitabine-oxaliplatin, gemtuzumab ozogamicin,glucarpidase, goserelin acetate, human papillomarvirus (HPV) bivalentvaccine, recombinant, HPV nonavalent vaccine, recombinant, HPVquadrivalent vaccine, recombinant, hydroxyurea, hyper-CVAD, ibritumomabtiuxetan, ibrutinib, ICE, idarubicin hydrochloride, idelalisib,ifosfamide, imatinib mesylate, imiquimod, interferon alfa-2b,recombinant, interleukin-2, intron A, iodine I 131 tositumomab andtositumomab, ipilimumab, irinotecan hydrochloride, irinotecanhydrochloride liposome, ixabepilone, ixazomib citrate, lanreotideacetate, lapatinib ditosylate, lenalidomide, lenvatinib mesylate,letrozole, leucovorin calcium, leuprolide acetate, lomustine,mechlorethamine hydrochloride, megestrol acetate, melphalan, melphalanhydrochloride, mercaptopurine, mesna, methotrexate, mitomycin C,mitoxantrone hydrochloride, MOPP, nanoparticle paclitaxel, necitumumab,nelarabine, netupitant and palonosetron hydrochloride, nilotinib,obinutuzumab, OEPA, ofatumumab, OFF, olaparib, omacetaxinemepesuccinate, ondansetron hydrochloride, OPPA, osimertinib,oxaliplatin, paclitaxel, paclitaxel albumin-stabilized nanoparticleformulation, PAD, palbociclib, palifermin, palonosetron hydrochloride,palonosetron hydrochloride and netupitant, pamidronate disodium,panitumumab, panobinostat, pazopanib hydrochloride, PCV, PEB,pegaspargase, peginterferon alfa-2b, pembrolizumab, pemetrexed disodium,plerixafor, pomalidomide, ponatinib hydrochloride, pralatrexate,prednisone, procarbazine hydrochloride, radium 223 dichloride,raloxifene hydrochloride, ramucirumab, rasburicase, R-CHOP, R-CVP,recombinant HPV bivalent vaccine, recombinant HPV nonavalent vaccine,recombinant HPV quadrivalent vaccine, recombinant interferon alfa-2b,regorafenib, R-EPOCH, rituximab, rolapitant hydrochloride, romidepsin,romiplostim, ruxolitinib phosphate, siltuximab, sipuleucel-T, sonidegib,sorafenib tosylate, STANFORD V, sunitinib malate, TAC, talc, talimogenelaherparepvec, tamoxifen citrate, temozolomide, temsirolimus,thalidomide, thioguanine, thiotepa, topotecan hydrochloride, toremifene,tositumomab and iodine I 131 tositumomab, TPF, trabectedin, trametinib,trastuzumab, trifluridine and tipiracil hydrochloride, uridinetriacetate, VAC, vandetanib, VAMP, VeIP, vemurafenib, venetoclax,vinblastine sulfate, vincristine sulfate, vincristine sulfate liposome,vinorelbine tartrate, VIP, vismodegib, vorinostat, XELIRI, XELOX,ziv-aflibercept, or zoledronic acid, for example.

Radiopharmaceuticals that may be delivered to a region or optionallycombined with a sealant for any of the embodiments described herein mayinclude but are not limited to calcium-47, carbon-11, carbon-11 choline,carbon-11-L-methyl-methionine, carbon-14, carbon-14 urea, chromium-51,chromium-51 red blood cells, chromium-51 ethylenediaminetetraaceticacid, cobalt-57, cobalt-57 cyanocobalamin, cobalt-58, cobalt-58cyanocobalamin, erbium-169, erbium-169 colloid, fluorine-18, fluorine-18desmethoxyfallypride, fluorine-18 florbetapir, fluorine-18fludeoxyglucose, fluorine-18 fluorocholine, fluorine-18 sodium fluoride,gallium-67, gallium-67 citrate, gallium-68, gallium-68 dotatoc,gallium-68 dotatate, gallium-68 PSMA, indium-111, indium-111 capromab,indium-111 chloride, indium-111 diethylenetriamine pentaacetic acid,indium-111 oxyguinoline, indium-111 pentetreotide, indium-111 satumomabpendetide, iodine-123, iodine-123 iobenguane, iodine-123 iodide,iodine-123 ioflupane, iodine-123 m-iodobenzylguanidine, iodine-123sodium iodide, iodine-125, iodine-125 human serum albumin, iodine-125iothalamate, iodine-131, iodine-131 human serum albumin, iodine-131sodium iodide, iodine-131 tositumomab, iron-59, krypton-81m,molybdenum-99, molybdenum-99 generator, nitrogen-13, nitrogen-13ammonia, oxygen-15, oxygen-15 water, phosphorus-32, phosphorus-32phosphate, radium-223, radium-223 dichloride, rubidium-82, rubidium-82chloride, samarium-153, samarium-153 EDTMP, selenium-75, selenium-75selenorcholestrerol, selenium-75 23-seleno-25-homo-tauro-cholate,sodium-22, sodium-24, strontium-89, strontium-89 chloride,technetium-99m, technetium-99m bicisate, technetium-99m colloid,technetium-99m diethylenetriaminepenta-acetic acid, technetium-99mdimercaptosuccinic acid, technetium-99m disofenin, technetium-99m ethylcysteinate dimer, technetium-99m exametazine, etium-99m exametazimelabelled leucocytes, technetium-99m hepatic iminodiacetic acid,technetium-99m human albumin, technetium-99m human albuminmacroaggregates or microspheres, technetium-99m human immunoglobulin,technetium-99m mebrofenin, technetium-99m medronate, technetium-99mmercaptoacetyltriglycine, technetium-99m mertiatide, technetium-99moxidronate, technetium-99m pentetate, technetium-99m pertechnetate,technetium-99m phosphonates and phosphates technetium-99m pyrophosphate,technetium-99m red blood cells, technetium-99m red blood cells(denatured), technetium-99m sestamibi, technetium-99m sulesomab,technetium-99m sodium pertechnetate, technetium-99m succimer,technetium-99m sulfur colloid, technetium-99m tetrofosmin,technetium-99m tilmanocept, thallium-201, thallium-201 chloride,xenon-133, xenon-133 gas, xenon-133 in isotonic sodium chloridesolution, yttrium-90, yttrium-90 chloride, yttrium-90 ibritumomabtiuxetan, yttrium-90 silicate, or the like. Any material that provides atherapeutic amount of radiation to a region may be used as aradiopharmaceutical for any of the embodiments described herein.

Antibiotics that may be delivered to a region or optionally combinedwith a sealant for any of the embodiments described herein may includebut are not limited to aminoglycosides (amikacin, gentamicin, kanamycin,neomycin, netilmicin, tobramycin, paromomycin, streptomycin,spectinomycin), ansamycins (geldanamycin, herbimycin, rifaximin),carbacephems (loracarbef), carbapenems (ertapenem, doripenem,imipenem/cilastatin, meropenem), cephalosporins (cefaclor, cefadroxil,cefalexin, cefalothin, cefalotin cefamandole, cefazolin, cefdinir,cefditoren, cefepime, cefixime, cefoperazone, cefotaxime, cefoxitin,cefpodoxime, cefprozil, ceftaroline fosamil, ceftazidime, ceftibuten,ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime), glycopeptides(dalbavancin, oritavancin, teicoplanin, telavancin, vancomycin),lincosamides (clindamycin, lincomycin), lipopeptides (daptomycin),macrolides (azithromycin, clarithromycin, dirithromycin, erythromycin,roxithromycin, troleandomycin, telithromycin), monobactams (aztreonam),nitrofurans (furazolidone, nitrofurantoin), oxazolidinones (linezolid,posizolid, radezolid, torezolid), penicillins and penicillincombinations (amoxicillin, amoxicillin/clavulanate, ampicillin,ampicillin/sulbactam, azlocillin, carbenicillin, cloxacillin,dicloxacillin, flucloxacillin, methicillin, mezlocillin, nafcillin,oxacillin, penicillin G, penicillin V, piperacillin,piperacillin/tazobactam, temocillin, ticarcillin,ticarcillin/clavulanate), polypeptides (bacitracin, colistin, polymyxinB), quinolones (ciprofloxacin, enoxacin, gatifloxacin, gemifloxacin,levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin,ofloxacin, trovafloxacin, grepafloxacin, sparfloxacin, temafloxacin),sulfonamides (mafenide, sulfacetamide, sulfadiazine, silversulfadiazine, sulfadimethoxine, sulfamethizole, sulfamethoxazole,sulfanilamide, sulfasalazine, sulfisoxazole.trimethoprim-sulfamethoxazole (co-trimoxazole), sulfonamidochrysoidine),tetracyclines (demeclocycline, doxycycline, minocycline,oxytetracycline, tetracycline), and others (arsphenamine, capreomycin,chloramphenicol, clofazimine, cycloserine, dapsone, ethambutol,ethionamide, fosfomycin, fusidic acid, isoniazid, metronidazole,mupirocin, platensimycin, pyrazinamide, quinupristin, rifabutin,rifampicin, rifapentine, streptomycin, thiamphenicol, tigecycline,tinidazole, trimethoprim), or the like.

Hemostatic and other sealing agents may be delivered to the targetregion and optionally combined with a sealant as described herein. Thehemostatic agent may comprise one or more of anti-fibrinolytics,Avitene®, BioGlue® Surgical Adhesive (CryoLife), biologic surgical GRFglues, bone wax, chitin, chitosan, COSEAL Surgical Sealant (BaxterHealthcare), cyanoacrylates, Dermabond™, EVISEL®, fibrin sealants,fibrin sealant powders, Floseal® Hemostatic Matrix (Baxter Healthcare),gelatin foams, Gelfoam®, Glubran 2™ (MediVogue), glutaraldehydecross-linked albumin, Helistat®, Hemaseel APR™ (Haemacure Corporation),Instat®, microfibrillar collagen, matrix hemostats, mineral zeolite,ostene, oxidized cellulose, Oxycel®, Quixil®, PEG polymers or hydrogels,platelet sealants, polymeric hydrogels, rFVIIa, SPONGOSTAN™ AbsorbableHaemostatic Gelatin Sponge (Ethicon), Superstat®, Surgicel® (Ethicon),Surgifoam™, Surgiflo™, TachoSil® (Baxter Healthcare), Thrombinar®,thrombins (thrombin-JMI, Evithrom®, thrombin with gelatin), TISSEL®(Baxter Healthcare), topical hemostats, Vitagel®, or Vivostat®.

Vasoconstrictors or vasopressors may be delivered to the target regionand optionally combined with a sealant as described herein may compriseone or more of adrenalin, dobutamine, droxidopa, epinephrine, ephedrine,isoproterenol, levophed, neosynephrine, norepinephrine, phenylephrine,or the like.

Any one or more of the therapeutic agents described herein may becombined with any one or more of the sealants described herein, anddelivered to the target region.

FIGS. 15A-15C, 16A-16C, 17A-17C, and 18A-18D all show exemplaryembodiments of sealant delivery devices configured to deliver aself-expanding gel sealant, such as a sealant made of a mixture ofpolyethylene glycol (PEG) and chitosan. For the above-mentioned figures,the terms “sealant” and “self-expanding gel” may be usedinterchangeably. Although reference is made to self-expanding sealants,the sealant may comprise a fully hydrated sealant that does notsubstantially expand, e.g. expands no more than about 5 percent byvolume when released from the delivery device to the target region.

The mixture of PEG and chitosan may have a ratio of PEG weight tochitosan weight within a range defined by any two of the followingratios: 0.01:1, 0.02:1, 0.04:1, 0.05:1, 0.1:1, 0.5:1, 1:1, 1:2, 1:3,1:4, 1:5, 1:6, 1:7, 1:8, 1:9, 1:10, 1:15, 1:20, 1:25, 1:50, or 1:100. Inuse, the ratio may have any value between any two aforementioned mixtureratios. The exact mixture may be chosen to improve the degradation timeof a sealant (to take on values of about 1, 2, 3, 5, 10, 12, 18, 24, 36,48 hours, or any value between any two aforementioned degradationtimes), to optimize the absorbability or solubility of blood, saline, orother fluids for the mixture, to determine the chitosan release rate, todetermine the extent of chitosan exposure to blood, saline, otherfluids, or surrounding tissues, to facilitate the ability of the mixtureto bind tissue, to facilitate the ability of the mixture to not bind totissue, to take on any preferred size, shape, or configuration asdescribed within this specification, or to be aerosolized.

FIGS. 15A-15C show a non-limiting exemplary embodiment of a sealantdelivery device having a delivery configuration (as shown in FIG. 15A)and a deployment configuration (as shown in FIGS. 15B-15C). The sealantdelivery device may comprise a single distal balloon, a catheter (suchas a Foley catheter), and a hemostatic agent or sealant, for example asealant comprising a self-expanding gel composed of a mixture of PEG andchitosan. The sealant may be disposed along a distal portion of thecatheter, and a sheath may be disposed along a distal portion of thecatheter, covering the sealant. The sealant can be a self-expanding gelas described herein such as a combination of PEG and chitosan, and oneof skill in the art will appreciate that many combinations of other gelsand therapeutic agents can be used.

FIG. 15A shows the delivery of a catheter comprising asealant-containing sheath 813 into a resection cavity 901 of a prostaticcapsule 900. The sealant 701 may for example comprise a PEG and chitosanhydrogel as described herein. Prior to delivery, the sealant of this orany embodiment described herein may be pre-loaded into the catheter, thesheath, or both. When in the pre-delivery (also referred to herein asthe delivery configuration), the sealant of this or any embodimentdescribed herein may be shaped to conform to the catheter, the sheath,or both. Similarly, the sheath 813 may be sized, shaped, and/orconfigured to conform to any size, shape, and/or configuration thesealant may have prior to delivery. The sheath 813 may be configured toprotect the sealant 701 from contact with liquids that may causepremature expansion, which could make the gel more difficult to place inthe cavity.

FIG. 15B shows the deployment of the sealant 701 into the resectioncavity 901 of the prostatic capsule 900. In the deploymentconfiguration, the distal balloon 808 may be inflated to partially orcompletely seal off the bladder B from the prostatic capsule 900 toprevent ingress of the sealant 701 into the bladder B such that only ornearly only the resection cavity 901 receives the sealant 701. In thedeployment configuration, the sheath 813 may be retracted so as toexpose the sealant 701 to the environment that surrounds it, such as theresection cavity, and may thereby release the self-expanding sealant 701to the resected or bleeding cavity. When in the post-delivery (alsoreferred to herein as the deployment configuration), the sheath 813 maybe retracted such that the sealant of this or any embodiment may besized, shaped, and/or configured to substantially match or nearly matchone or more of the size, shape, profile, or surface profile of theremaining tissue defining the resected cavity. Moreover, thecross-section of the expanded sealant may take on any shape appropriateto engage the surface of the remaining tissue, including a circle, anellipse, a triangle, a square, a rectangle, a polygon, or anycombination thereof.

FIG. 15C shows expansion of the sealant in order to engage the remainingtissue defining the cavity edge 904. As the sealant 701 (e.g. PEG andchitosan) absorbs various materials from the resection cavity 901, suchas blood, saline, etc., the sealant may expand to fill the volume of theresection cavity 901, for example by engaging the tissue along thecavity edge 904. The sealant delivery device or the catheter (or both)of this or any embodiment described herein may be removed acutely or mayremain indwelling for a period of time (e.g. from about 1 to about 60minutes, from about 1 to about 24 hours, from about 1 to about 7 days,or any combination of any amount of time within those ranges). Uponremoval of the sealant delivery device, any sealant that remains withinmay erode in one or more of many ways, for example with dissolution,degradation, washing away, or erosion. The eroded sealant may passthrough the urethra and out of the body.

FIGS. 16A-16C show a sealant delivery device and a method of treatingtissue. The delivery device may have a delivery configuration and adeployment configuration. The sealant delivery device may comprise adistal balloon, an expandable support (for example a proximal balloon),a catheter, a self-expanding gel sealant, and a sheath disposed along adistal portion of the catheter and covering the sealant. Any of theembodiments described herein may comprise an expandable support, forexample one or more inflatable balloons as illustrated in numerousembodiments. The expandable support member of this or any embodiment maycomprise one or more of a self-expanding nitinol stent, a polymer-basedstent, a dissolvable stent, an inflatable balloon, one or more staples,one or more sutures, one or more barbs, or any combination thereof. Theexpandable support of this or any embodiment may comprise an inflatableballoon whose shape when expanded in a target region expands to have twobulbs and a slender section in between the two bulbs, similar to abarbell (also referred to herein as a dumbbell) or a guitar body. Forexample, if a barbell-shaped inflatable balloon expandable supportembodiment was disposed within a prostate, one of the two bulbs may besituated in the bladder while the other of the two bulbs may be situatedin the prostate with the slender section in between the two bulbsspanning the bladder neck. The expandable support may be substantiallysurrounded by the sealant so that as the expandable support is expandedit may aid in distributing, dispersing, or dispensing the sealant to atarget tissue region. The self-expanding gel matrix may be mechanicallybound to the catheter (for instance with sutures, staples, etc.) orchemically bound to the catheter (such as with an adhesive, etc.). Insome embodiments, once the balloon is deflated for removal, theself-expanding gel may collapse and be removed with the catheter so thatno amount or a negligible amount of the gel sealant may be left in theprostate for natural degradation.

FIG. 16A shows a sealant delivery device in the delivery configurationwherein neither of the two balloons is inflated. The sheath 813substantially covers the self-expanding gel sealant and the expandablesupport 806 (e.g. proximal balloon) in the delivery configuration. Thesheath 813 may be retracted in the deployment configuration to exposeone or more of the self-expanding gel sealant and the proximal balloon806 as shown in FIGS. 16B-16C.

FIG. 16B shows the sealant delivery device in the deploymentconfiguration. The distal balloon 808 of the sealant delivery device maybe expanded so as to partially or completely seal off distal opening 903and the bladder B from the prostatic capsule 900 to inhibit ingress intothe bladder B and so that only or nearly only the resection cavity 901receives the sealant 701. The sheath 813 may be retracted to expose theself-expanding gel to the surrounding environment.

As the self-expanding gel is exposed to the fluids of the surroundingenvironment, the gel may self-expand. This self-expansion may becombined with expansion of the proximal balloon 806. As FIG. 16C shows,the proximal balloon 806 or expandable support may aid in this expansionby urging the sealant radially outward to engage the tissue on the wallof the cavity (e.g. the cavity edge 904). This may also allow forengagement of the sealant 701 with the cavity edge 904 with decreasedamounts of gel sealant required, and may alternatively or in combinationreduce the amount of sealant that may erode away, which may bebeneficial. Expanding the expandable support may help compress thesealant into the walls of the resected cavity or cavity edge 904 and mayallow the self-expanding gel to reach and compress into surfaces ofresected cavities which may have non-uniform geometries. Mechanicalcompression or the electro-binding effects of chitosan to blood cellsmay aid in hemostasis.

FIGS. 17A-17C show a non-limiting exemplary embodiment of a sealantdelivery device having a delivery configuration and a deploymentconfiguration. The sealant delivery device may comprise an expandablesupport or proximal balloon surrounded by a sealant, for example, aself-expanding gel sealant, a sheath disposed along a distal portion ofa catheter, and a catheter. The sheath may cover the sealant, theexpandable support, or both. When expanded, the expandable support mayaid in distributing, dispersing, or dispensing the sealant to a targetas described herein.

FIG. 17A shows the sealant delivery device in the deliveryconfiguration. The non-inflated expandable support or proximal balloon806 may be surrounded by the self-expanding gel sealant. The expandablesupport and the self-expanding gel may be disposed within the sheath813. The sheath 813 may be disposed on the distal end of the catheter.The distal end of the catheter comprising the sheath 813 may be disposedthrough a proximal opening 902 of the tissue.

FIG. 17B shows the sealant delivery device in the deliveryconfiguration. The sheath 813 may be retracted from the self-expandinggel sealant prior to expansion of the proximal balloon 806, thusexposing the self-expanding gel to the fluids of the surroundingenvironment. The self-expanding gel may comprise a first amount ofhydration prior to retracting the sheath 813, and a second amount ofhydration after removal of the sheath 813, in which the second amount ofhydration may be greater than the first amount of hydration.

FIG. 17C shows the sealant delivery device after the self-expanding gelhas expanded with increased hydration and the expandable supportexpanded. Expanding the expandable support (or proximal balloon) mayhelp compress the sealant 701 into the walls (e.g., cavity edge 904) ofthe resected cavity and may allow the self-expanding gel to reach andcompress into one or more surfaces of the resected cavity and may bebeneficial in cavities having non-uniform geometries. Using a distalballoon 808 to seal the bladder B (as was illustrated, for example, inFIGS. 15A-15C and 16A-16C for certain exemplary embodiments) may not benecessary in many instances. In some instances, it may be beneficial toallow a portion of the self-expanding gel to expand partially into thebladder to address bleeding at or near the bladder neck BN. Also, as theself-expanding gel can readily erode away, having a portion of the gelexpand into the bladder neck BN can be acceptable in many instances.

FIGS. 18A-18D show an embodiment of a sealant delivery device andrelated method. The sealant delivery device may comprise three or moreballoons. The sealant delivery device may comprise a distal balloon toseal the bladder, an expandable support or proximal balloon surroundedby a sealant, and a cap balloon proximal to the expandable support. Thedevice may further comprise a self-expanding gel sealant, a flush port,a catheter, and a sheath disposed along a distal portion of a catheter,the sheath covering the sealant, the expandable support, and the capballoon. The exemplary embodiments illustrated in FIGS. 18A-18D or anyof the embodiments described herein can deliver non-hemostatic materialsto the resected cavity, such as therapeutic agents as described herein,water, or saline.

FIG. 18A shows a sealant delivery device positioned within the resectioncavity 901 of the prostatic capsule 900 in the delivery configuration.The three balloons are not inflated, or are substantially uninflated, soas to provide a decreased profile while being delivered to and placedwithin the cavity. The tissue may comprise a prostatic capsule 900 of aprostate, wherein the proximal opening 902 comprises an opening to aurethra and the distal opening 903 comprises a bladder neck BN betweenthe prostate and a bladder B. The cap balloon 814 may be placed at theproximal opening 902 of the cavity. The distal balloon 808 may be placedat the distal opening 903 of the cavity.

FIG. 18B shows the sealant delivery device in the delivery configurationwith the sheath 813 retracted, exposing the self-expanding gel sealantto the fluids of the surrounding environment. Once the sheath 813 hasbeen retracted, the distal balloon 808 and the cap balloon 814 may beinflated simultaneously, sequentially, or independently of one anotherto isolate the prostatic capsule 900 or resection cavity 901 from thebladder B or any other surrounding tissues. Isolating the prostaticcapsule 900 or resection cavity 901 may inhibit therapeutic agentsdelivered to the region from reaching non-targeted tissue, such asselect portions of prostatic tissue. Removal of the sheath 813 may alsoexpose the self-expanding gel sealant to the fluids of the surroundingenvironment as described herein. Material (for instance, sealant or atherapeutic agent) may optionally be passed into the resection cavity901 through a flush port (as shown in FIG. 18D) once the distal balloon808 and cap balloon 814 have been inflated and have sealed off theresection cavity 901. The flush port may be configured to both deliverone or more materials to the resection cavity region and to removematerial through such means as previously described. In someembodiments, the flush port may be configured to deliver material to theresection cavity region. In some embodiments, the flush port may beconfigured to remove material from the resection cavity region.

FIG. 18C shows the expandable support expanded to compress theself-expanding gel into the edge of the resection cavity 901 after thecap balloon 814 and distal balloon 808 have been expanded. In thismanner, the sealant 701 may contact all or nearly all of the surfaces ofresection cavity 901 or other body cavities, for example those havingnon-uniform geometries. After the expandable support has been expandedto engage the cavity edge 904 with the self-expanding gel sealant,additional material (for instance, a pain reliever or a hemostaticagent) may optionally be passed into the resected cavity through theflush port.

FIG. 18D shows the flush port 815 on a proximal portion of the sealantdelivery device. The flush port 815 may comprise a single hole or poreon the catheter shaft situated between the expandable support and thecap balloon 814 as shown. Alternatively or in combination, the flushport may comprise a plurality of holes. The size and shape of the one ormore holes or pores may take on any form sufficient to allow any of theaforementioned materials (e.g. hemostatic agents, therapeutic agents,drugs, water, saline) to pass through. Such shapes for one or more holesmay include, but are not limited to, a circle, an ellipse, a triangle, asquare, a rectangle, a polygon, and the like. The position of the flushport 815 may be near the expandable support so as to deliver material toa target region, for example a region comprising resected tissue or amalignant lesion. This placement of the one or more flush ports betweenthe expanded distal and cap balloons can decrease amounts of materialthat are released to bladder B and urethra, which can decrease unwantedexposure of untargeted tissue(s) to the material. This can be helpfulwhen the material comprises an anti-cancer material, such as atherapeutic agent to treat cancer like a chemotherapeutic or aradiotherapeutic.

After delivering the sealant to the resected cavity, it may be helpfulto remove excess material, such as that left over after delivery of thesealant or other material delivered through the flush port 815. Theflush port 815 may remove excess material easily by flushing the areawith saline, for example.

Many embodiments may comprise one or more radioactive seeds configuredfor delivery to the target site, which can be combined with the tissuesealant as described herein. Radioactive seeds and delivery devices andtreatments suitable for combination with tissue sealants as disclosedherein are described in PCT/US2015/037521, filed Jun. 24, 2016, entitled“TISSUE SAMPLING AND CANCER TREATMENT METHODS AND APPARATUS”, the entiredisclosure of which is incorporated herein by reference. The radioactiveseeds may comprise any radioactive element as described herein, and maycomprise seeds and radioactive dosimetry similar to known brachytherapy,such as interstitial brachytherapy and contact brachytherapy. Aplurality of radioactive seeds can be combined with tissue sealant toprovide localized delivery of radiation suitable for the treatment ofcancer. The seeds can be sized and shaped in many ways and may compriseone or more of many shapes such as cylindrical rods, spheres, prolateellipsoids, oblate ellipsoids, rice grain shaped, or other shapes. Theseeds may comprise a smooth outer surface in order to allow passagethrough the urethra, for example. Each of the seeds comprises a maximumdimension across within a range from about 0.1 mm to about 5 mm, forexample from about 0.2 mm to about 1 mm, such that the seeds can easilypass though the urethra. Alternatively, the seeds may comprise anirregular surface, a rough surface, barbs or other retention structuressuch that the seed is retained in the target tissue. The seeds may havethe benefit of not being absorbed by tissue, and may remain external tothe target tissue, for example. The seeds may be provided in a matrixwith the gel and eroded away with the gel, for example. Any of theradiotherapeutics (including those in the form of seeds) may be used forbrachytherapy, which itself may comprise interstitial brachytherapy orcontact brachytherapy. Radiotherapeutics for brachytherapy may comprisea low-dose rate (less than about 2 Gy/h), a medium-dose rate (from about2 Gy/h to about 12 Gy/h), a high-dose rate (greater than about 12 Gy/h)or a pulsed-dose rate (short pulses of radiation, typically about onceper hour), or any combination thereof. The number of seeds that may beused within a single sealant or for a given treatment may be about 1, 5,10, 20, 30, 40, 50, 75, 100, 125, 150, 200, or 300 seeds, or any valuebetween any two previously listed amounts.

The seeds and sealant may be configured in many ways and are well suitedfor combination with seeds used in brachherein and may comprise but arenot limited to calcium-47, carbon-11, carbon-11 choline,carbon-11-L-methyl-methionine, carbon-14, carbon-14 urea, cesium-131,cesium-137, chromium-51, chromium-51 red blood cells, chromium-51ethylenediaminetetraacetic acid, cobalt-57, cobalt-57 cyanocobalamin,cobalt-58, cobalt-58 cyanocobalamin, cobalt-60, erbium-169, erbium-169colloid, fluorine-18, fluorine-18 desmethoxyfallypride, fluorine-18florbetapir, fluorine-18 fludeoxyglucose, fluorine-18 fluorocholine,fluorine-18 sodium fluoride, gallium-67, gallium-67 citrate, gallium-68,gallium-68 dotatoc, gallium-68 dotatate, gallium-68 PSMA, indium-111,indium-111 capromab, indium-111 chloride, indium-111 diethylenetriaminepentaacetic acid, indium-111 oxyguinoline, indium-111 pentetreotide,indium-111 satumomab pendetide, iodine-123, iodine-123 iobenguane,iodine-123 iodide, iodine-123 ioflupane, iodine-123m-iodobenzylguanidine, iodine-123 sodium iodide, iodine-125, iodine-125human serum albumin, iodine-125 iothalamate, iodine-131, iodine-131human serum albumin, iodine-131 sodium iodide, iodine-131 tositumomab,iridium-192, iron-59, krypton-81m, molybdenum-99, molybdenum-99generator, nitrogen-13, nitrogen-13 ammonia, oxygen-15, oxygen-15 water,palladium-103, phosphorus-32, phosphorus-32 phosphate, radium-223,radium-223 dichloride, rubidium-82, rubidium-82 chloride, ruthenium-106,samarium-153, samarium-153 EDTMP, selenium-75, selenium-75selenorcholestrerol, selenium-75 23-seleno-25-homo-tauro-cholate,sodium-22, sodium-24, strontium-89, strontium-89 chloride,technetium-99m, technetium-99m bicisate, technetium-99m colloid,technetium-99m diethylenetriaminepenta-acetic acid, technetium-99mdimercaptosuccinic acid, technetium-99m disofenin, technetium-99m ethylcysteinate dimer, technetium-99m exametazine, etium-99m exametazimelabelled leucocytes, technetium-99m hepatic iminodiacetic acid,technetium-99m human albumin, technetium-99m human albuminmacroaggregates or microspheres, technetium-99m human immunoglobulin,technetium-99m mebrofenin, technetium-99m medronate, technetium-99mmercaptoacetyltriglycine, technetium-99m mertiatide, technetium-99moxidronate, technetium-99m pentetate, technetium-99m pertechnetate,technetium-99m phosphonates and phosphates technetium-99m pyrophosphate,technetium-99m red blood cells, technetium-99m red blood cells(denatured), technetium-99m sestamibi, technetium-99m sulesomab,technetium-99m sodium pertechnetate, technetium-99m succimer,technetium-99m sulfur colloid, technetium-99m tetrofosmin,technetium-99m tilmanocept, thallium-201, thallium-201 chloride,xenon-133, xenon-133 gas, xenon-133 in isotonic sodium chloridesolution, yttrium-90, yttrium-90 chloride, yttrium-90 ibritumomabtiuxetan, yttrium-90 silicate, or the like. Any material that provides atherapeutic amount of radiation to a region may be used as a radioactiveseed for any of the embodiments described herein. Any of theaforementioned radioactive seeds may be used, alone or in combinationwith others, as a radiopharmaceutical.

FIGS. 19A-19D show a sealant delivery device comprising a catheter and apolymer sheath. The sealant delivery device may comprise a catheter,distal balloon, and proximal balloon as described herein and may besubstantially similar to other dual balloon embodiments describedherein. The sealant delivery device may be delivered through the urethrasuch that distal balloon and proximal balloon are fully inserted intothe bladder and prostatic capsule, respectively, as described herein.The sealant delivery device may further comprise a sheath which maycover one or both of the proximal and distal balloons when in a deliveryconfiguration (as shown in FIG. 19A). The sheath may for examplecomprise a polymer sheath as shown, an elastic sheath (for example asshown in FIGS. 20A-20B), or a substantially rigid sheath (for example asshown in FIGS. 15A-18C). Any of the embodiments described herein maycomprise a sheath to aid in device delivery and/or provide for timeddelivery of the sealant from the device.

An external surface of the proximal balloon may be coated in ahemostatic agent, for example a sealant. The proximal balloon may befully coated or partially coated with the hemostatic agent.Alternatively or in combination, the distal balloon may be fully coatedor partially coated in a hemostatic agent. The sealant may be any of thesealants described herein. The sealant may for example be aself-expanding gel sealant which expands on exposure to fluids such asblood or saline. The sheath may be disposed about the sealant-coatedballoon(s) during delivery so as to allow for dry delivery of theself-expanding sealant and prevent expansion of the sealant until thesheath has been retracted into the deployment configuration (as shown inFIGS. 19B-19C).

FIG. 19A shows the sealant delivery device in the deliveryconfiguration. One or more of the proximal balloon 806 and distalballoon 808 may be coated in a hemostatic agent, for example, aself-expanding gel sealant. The sheath 816, for example a polymersheath, may be disposed about the sealant-coated balloon(s) so as toallow for dry delivery of the self-expanding sealant and preventexpansion of the sealant during delivery.

FIG. 19B shows the sealant delivery device in the deploymentconfiguration. The sheath 816 may be coupled to the distal balloon 808and/or a region of the catheter distal to the distal balloon 808.Expansion of the distal balloon 808 may cause the sheath 816 to retractfrom the sealant-coated proximal balloon 806 and expose theself-expanding gel sealant to the fluids within the cavity. Theself-expanding gel sealant may then expand upon contact with the cavityfluids to fill the cavity and provide hemostasis at the cavity edge 904.

FIG. 19C shows the sealant delivery device in the deploymentconfiguration with the proximal balloon 806 expanded. The proximalballoon 806 may be expanded while the sheath 816 is being retracted(e.g., at or nearly at the same time as the distal balloon 808 isexpanded) or after the sheath 816 has been retracted and the sealant hasbeen exposed to the cavity. Expansion of the proximal balloon 806 mayfacilitate distribution of the sealant to the cavity wall, which may beof particular use when the cavity has a non-uniform geometry or when itmay be desired to reduce the amount of sealant delivered to the tissue.Expansion of the proximal balloon 806 may alternatively or incombination provide compression to the cavity wall, which may furtherenhance hemostasis. The proximal balloon 806 may comprise a compliantmaterial or non-compliant material. The proximal balloon 806 may, forexample, comprise a compliant material which may allow the proximalballoon 806 to conform to the volume of the cavity defined by the cavityedge 904 when expanded in order to further enhance sealant distribution,especially in volumes with non-uniform geometries.

FIG. 19D shows the cavity following removal of the sealant deliverydevice. The proximal and distal balloons of the sealant delivery devicemay be deflated after a pre-determined amount of time and the cathetermay be retracted out of the cavity through the urethra. Some or all ofthe hemostatic agent may remain within the cavity to continue to preventbleeding after the device has been removed. As shown here, by expandingthe proximal balloon to facilitate sealant delivery, the sealantremaining within the cavity may have a non-uniform distribution, withsome areas of the cavity (for example the cavity walls) receiving moresealant than other areas (for example the internal space defined by thecavity walls). Non-uniform distribution of the sealant may be beneficialwhen trying to conserve the amount of sealant delivered to the tissueand/or when the bleeding tissue has a non-uniform geometry. Any sealantthat remains within the cavity following device removal may erode in oneor more of many ways, for example with dissolution, degradation, washingaway, or erosion. The eroded sealant may pass through the urethra andout of the body.

FIGS. 20A-20B show a sealant delivery device comprising an elasticsheath. The sealant delivery device may comprise a catheter and aproximal balloon as described herein and may be substantially similar toother single proximal balloon embodiments described herein. The sealantdelivery device may further comprise a sheath which covers the proximalballoon when in a delivery configuration (as shown in FIG. 20A). Thesheath may, for example, comprise any of the sheaths described herein.The sheath may, for example, comprise an elastic sheath. An externalsurface of the proximal balloon may be fully coated or partially coatedin a hemostatic agent, for example a sealant. The sealant may be any ofthe sealants described herein. The sealant may for example be aself-expanding gel sealant.

FIG. 20A shows the sealant delivery device in the deliveryconfiguration. The proximal balloon 806 may be coated in a hemostaticagent, for example a self-expanding gel sealant. The elastic sheath 816may be disposed about the sealant-coated balloon during delivery so asto allow for dry delivery of the self-expanding sealant and preventexpansion of the sealant until the sheath 816 has been detached into thedeployment configuration (as shown in FIG. 20B). The sheath 816 may becoupled to a region of the catheter distal to the proximal balloon 806.The sheath 816 may further be detachably coupled to the proximal balloon806 and/or a region of the catheter proximal to the proximal balloon806.

FIG. 20B shows the sealant delivery device in the deploymentconfiguration. The sheath 816 may be coupled to a region of the catheterdistal to the proximal balloon 806. Expansion of the proximal balloon806 may cause the sheath 816 to detach from the proximal balloon 806and/or the region of the catheter proximal to the proximal balloon 806.Detachment of the proximal end of the sheath 816 may cause the sheath tomigrate towards the attachment to the region distal to the proximalballoon 806 due to the elasticity of the sheath and expose theself-expanding gel sealant to the fluids within the cavity. Theself-expanding gel sealant may then expand upon contact with the cavityfluids to fill the cavity and provide hemostasis at the cavity edge 904.Expansion of the proximal balloon 806 may aid in delivery anddistribution of the sealant to the cavity wall as described herein.

In any of the embodiments described herein, the sealant may be deliveredthrough a sealant port (also referred to herein as a sealant deliveryport) as described herein, either in addition to or as an alternative todelivery of the sealant as a coating on one or more balloons. The sheathmay be disposed over a region of the catheter adjacent the sealant portand coupled to one or more of the distal balloon or proximal balloon.When the sheath is flexible

-   -   for example when the sheath comprises a polymer sheath or an        elastic sheath, expansion of the distal balloon and/or proximal        balloon may cause the sheath to retract or detach from the        region in order to expose the sealant port and allow the sealant        to flow into the resection cavity. When the sheath is rigid or        substantially non-compliant, retraction of the sheath as        described herein (e.g. FIGS. 15A-18C) from the region may expose        the sealant port and allow the sealant to flow into the        resection cavity.

Alternatively or in combination, in any of the embodiments describedherein the sealant may be delivered through one or more of the balloons(e.g. through pores in the proximal balloon or the distal balloon) asdescribed herein. The sheath may be disposed over a region of thecatheter comprising the sealant-delivering balloon(s). Retraction ordetachment of the sheath as described herein may expose thesealant-delivering balloon(s) and allow the sealant to flow in to theresection cavity.

In any of the embodiments described herein, the sheath may alternativelyor in combination be used to maintain the expandable support in a lowprofile delivery configuration. The expandable support may for examplecomprise an expandable stent. The expandable stent may comprise ashape-memory material, for example nitinol. The sheath in the deliveryconfiguration may compress the expandable support and retraction of thesheath may allow the expandable support to expand to an expandedconfiguration as described herein.

FIG. 21A shows a front view of a prostate, urethra U, and bladder B.FIG. 21B shows a side view of a prostate, urethra U, and bladder B.Embodiments of the sealant delivery device disclosed herein may be usedto treat any tissue volume or cavity comprising a proximal opening 902and a distal opening 903, the proximal and distal openings allowing thetissue volume to fluidly communicate with other organs or parts of thebody adjacent the tissue volume. For example, the tissue volume maycomprise a prostatic capsule 900 of a prostate, the prostate having aproximal opening 902 to the urethra and a distal opening 903 to thebladder B at the bladder neck BN. The sealant delivery device may beadvanced into the urethral os 50, through the urethra into the prostaticcapsule 900, and through the bladder neck BN into the bladder B asdescribed herein. As described herein, the sealant delivery device mayfurther be configured to or positioned to make contact with and/or avoidor reduce contact with one or more tissue structures within theprostatic capsule 900. For example, the device may be configured toavoid or reduce contact with sensitive tissue structures of theprostatic capsule 900 like the verumontanum V, which acts as a landmarknear the entrance of the seminal vesicles, as described herein. Althoughshown near a central portion of the prostatic capsule 900, it will beunderstood by one of ordinary skill in the art that the verumontanum Vcan be located closer to the proximal opening 902 (e.g. urethra orsphincter) than shown.

FIGS. 22A-22E show a catheter 2200 with an expandable support assemblyor inflatable balloon assembly comprising a single compliant distalballoon 808 to provide compression hemostasis. The inflatable balloonassembly may be attached adjacent the distal end of the catheter 2200 atone or more locations. The catheter 2200 may be configured to beadvanced into the space enclosed with the prostatic capsule 900 (e.g.the cavity) through a proximal opening 902 into the enclosed space. Thecatheter 2200 may be delivered into the space such that a distal end ofthe inflatable balloon assembly is positioned adjacent the bladder neckand/or partially within the bladder. The inflatable balloon assembly mayhave an expanded configuration configured to anchor along a bladder neckadjacent the distal opening 903 to the prostatic capsule 900 and atleast partially fill the space enclosed by the prostatic capsule. Theinflatable balloon assembly may be expanded so as to apply compressionto the tissue to promote hemostasis in the tissue. The inflatableballoon assembly may, for example, be expanded so as to seal the distalopening 903. The inflatable balloon assembly may be expanded to a targetpressure to apply compression to the tissue. The target pressure may bedetermined in response to a measured blood pressure of a patient. Thetarget pressure may, for example, be slightly higher than the measuredblood pressure in order to close bleeding vessels. The target pressuremay for example be within a range of about 5% to about 100% (forexample, about 50%) above the measured systolic blood pressure in orderto close bleeding vessels. Alternatively or in combination, theinflatable balloon assembly may be inflated to a pre-determined targetvolume and/or shape. The inflatable balloon assembly may, for example,be inflated to a volume and/or shape which corresponds to a resectedtissue volume and/or shape.

FIG. 22A shows an inflatable balloon assembly 2210 comprising a uniformcompliance. The inflatable balloon assembly 2210 may comprise a unitarycompliant material. The inflatable balloon assembly may, for example,comprise a uniform thickness. When inflated in the tissue space, theinflatable balloon assembly 2210 may, for example, comprise an hourglassshape having a distal bladder region 2212, a proximal prostatic region2214, and a neck region 2213 therebetween. The inflatable balloonassembly 2210 may be long enough to fill the prostate and extrude intothe bladder.

FIG. 22B shows an inflatable balloon assembly 2210 comprising anon-uniform compliance. Non-uniform compliance may, for example, beachieved by providing a less compliant region 2201 (for example a regionmade of a less compliant material or a region with a thicker balloonwall) within the inflatable balloon assembly. Non-uniform compliancemay, for example, be achieved by an inflatable balloon assembly withnon-uniform thickness. The region (or regions) of non-uniform complianceand/or thickness may be configured to provide the inflatable balloonassembly 2210 with a pre-determined shape. The region (or regions) ofnon-uniform compliance and/or thickness may be configured to be expandedin a stepwise manner such that one or more regions of the inflatableballoon assembly (for example the distal bladder region 2212, proximalprostatic region 2214, and/or neck region 2213) expands before one ormore other regions of the inflatable balloon assembly. The distalbladder region 2212 may for example comprise a rigid balloon.

FIG. 22C shows a front view of an inflated inflatable balloon assembly2210 comprising a non-uniform compliance, for example having a region ofreduced compliance as shown in FIG. 22B. FIG. 22D shows a side-view ofthe inflated inflatable balloon assembly. The region of non-uniformcompliance may, for example, comprise a region of increased thicknesscorresponding to the neck region 2203 of the inflated balloon comparedto the proximal prostatic region 2204 and/or the distal bladder region2202 of the inflatable balloon assembly 2210. The neck region 2203 maybe thicker than the proximal prostatic region 2204 and/or the distalbladder region 2202 so as to reduce compression on and preventdistension of the bladder neck 2203 during expansion of the inflatableballoon assembly 2210. Alternatively or in combination, the distalbladder region 2212 may be thicker than the neck region 2213 and/or theproximal prostatic region 2214 so as to provide traction resistance todilation of the peripheral sphincter. One or more regions of theinflatable balloon may be inflated to one or more target pressureschosen so as to close bleeding vessels.

FIG. 22E shows an inflatable balloon assembly comprising an adjustablelength feature. Any of the embodiments described herein may furthercomprise an adjustable length feature 2220. The adjustable lengthfeature 2220 may be configured to adjust the length (and volume) of theinflatable balloon assembly prior to or after delivery into the tissue.The adjustable length feature 2220 may, for example, comprise anon-compliant sheath with tear-away sections as shown. Tearing away oneor more of the sections may increase the volume of balloon available forexpansion, thereby increasing the volume and/or shape of the expandedballoon. Alternatively or in combination, the adjustable length feature2220 may comprise a retractable cover or an elastomeric sheath disposedover at least a portion of the inflatable balloon assembly. Retractionof the cover or elastomeric sheath may increase the volume of balloonavailable for expansion. In some instances, the elastomeric sheath maybe retracted by increasing the pressure of the balloon assembly.Alternatively or in combination, the cover or sheath may be manuallyretracted. The adjustable length feature 2220 may comprise a hyperechoicmaterial to allow for the use of ultrasound to visualize the position ofthe sheath in the tissue. Alternatively or in combination, theadjustable length feature 2220 may comprise a radiopaque material toallow for the use of x-ray imaging to visualize the sheath. Visualizingthe adjustable length feature 2220 may allow for better placement of theinflatable balloon assembly and/or adjustment of the length of theballoon prior to, during, or after inflation.

FIGS. 23A-23C show a catheter 2200 with inflatable balloon assemblycomprising two balloons to provide compression hemostasis. Theinflatable balloon assembly may be shaped substantially similar to thatof FIGS. 22A-22E. The inflatable balloon assembly may, for example,comprise a proximal balloon and a distal balloon. The catheter 2200 maybe delivered into the tissue space such that the distal balloon ispositioned adjacent the bladder neck and/or within the bladder. Aportion of the proximal balloon may extend from the distal balloon inthe bladder, through the bladder neck, and into the prostatic capsule.The inflatable distal balloon may have an expanded configurationconfigured to anchor along a bladder neck adjacent the distal opening tothe prostatic capsule. The proximal balloon may have an expandedconfiguration configured to at least partially fill the space enclosedby the prostatic capsule and the bladder neck. The inflatable balloonassembly may be expanded so as to apply compression to the prostatictissue and/or bladder neck to promote hemostasis in the tissue asdescribed herein. The distal balloon of the inflatable balloon assemblymay, for example, be expanded so as to seal the distal opening. Theinflatable balloon assembly may be expanded to a target pressure,volume, and or shape to apply compression to the tissue as describedherein.

FIG. 23A shows an inflatable balloon assembly comprising a proximalballoon 806 attached to a distal balloon 808 in a low-profile deliveryconfiguration. The proximal balloon 806 and the distal balloon 808 maybe continuous with one another or the proximal balloon 806 may bedisposed about and attached or adhered to the distal balloon 808 asshown. The inflatable balloon assembly may be attached adjacent thedistal end of the catheter 2200 at one or more locations.

FIG. 23B shows a front-view of an inflated inflatable balloon assemblycomprising a proximal balloon 806 attached to a distal balloon 808. FIG.23C shows a side-view of the inflated inflatable balloon assembly. Thedistal balloon 808 may comprise any of the balloon shapes describedherein. The distal balloon 808 may for example comprise a rigid toroidalballoon. The distal balloon 808 may be inflated to seal the bladderneck. Alternatively or in combination, the distal balloon 808 may act asan anchor at the bladder neck in order to prevent unintentional movementand/or removal of the inflatable balloon assembly. The proximal balloon806 may comprise any of the balloon shapes described herein. Theproximal balloon 806 may comprise a very compliant or moderatelycompliant material. The proximal balloon 806 may be inflated to apre-determined pressure, shape, or volume as described herein. Theproximal balloon 806 may for example be inflated so as to re-approximatetissue to the organ wall and/or provide designed, direct compression onsurface vessel within the tissue to establish hemostasis. The region ofthe proximal balloon 806 within the bladder neck may be inflated inorder to seal the bladder neck and provide compression to the bladderneck to prevent or stop bleeding.

FIGS. 24A-24D show a catheter with inflatable balloon assemblycomprising adjustable balloons to provide compression hemostasis. Theinflatable balloon assembly may comprise a distal balloon 808 and aproximal balloon 806. The catheter may be delivered into the tissuespace such that the distal balloon 808 is positioned adjacent thebladder neck and/or within the bladder. The proximal balloon 806 may bepositioned in the prostatic capsule. The inflatable distal balloon 808may have an expanded configuration configured to anchor along a bladderneck adjacent the distal opening to the prostatic capsule. The proximalballoon 806 may have an expanded configuration configured to at leastpartially fill the space enclosed by the prostatic capsule. Theinflatable balloon assembly may be expanded so as to apply compressionto the prostatic tissue and/or bladder neck to promote hemostasis in thetissue as described herein. The distal balloon 808 of the inflatableballoon assembly may, for example, be expanded so as to seal the distalopening. The inflatable balloon assembly may be expanded to a targetpressure, volume, and or shape to apply compression to the tissue asdescribed herein. One or more of the distal balloon 808 or proximalballoon 806 may be adjustable within the tissue. For example, theproximal balloon 806 may be selectively positionable within theprostatic capsule.

FIGS. 24A-24B shows an inflatable balloon assembly comprising a proximalballoon 806 and a distal balloon 808 in a low-profile deliveryconfiguration. The distal balloon 808 may be attached adjacent thedistal end of the catheter at one or more locations. The proximalballoon 806 may be attached to the catheter at one or more locationsproximal to the distal balloon 808. The proximal balloon 806 may beattached to an adjustable sheath 2220 configured to re-position theproximal balloon 806 when actuated (for example by a physician). Thesheath 2220 may for example be moved distally or proximally along thecatheter in order to move the proximal balloon 806 distally orproximally, respectively. The proximal balloon 806 may be re-positionedprior to, during, or after inflation of the proximal balloon 806, distalballoon 808, or both. The location of the proximal balloon 806 relativeto the distal balloon 808 may be fixed following re-positioning to adesired location within the prostatic capsule. The proximal balloon 806may be fixed externally so as to assure movement between the distalballoon 808 and the proximal balloon 806 remains unchanged while thecatheter is in place. The distance between the proximal and distalballoons may alternatively or in combination be fixed between theballoons by providing compression or extension between the balloons fortargeted compressive therapy. The proximal balloon 806 may comprise anyshape described herein or desired. The proximal balloon 806 may, forexample, comprise a toroidal shape (as in FIG. 24A) or a cylindricalshape (as in FIG. 24B). The length of the proximal balloon 806 may beadjustable as described herein so as to adjust the shape of the inflatedballoon. In some instances, it may be beneficial to provide aninflatable balloon assembly without a distal balloon 808 as shown inFIG. 24B.

FIG. 24C shows a front-view of an inflated inflatable balloon assemblycomprising a proximal balloon 806 and a distal balloon 808. FIG. 24Dshows a side-view of the inflated inflatable balloon assembly. Thedistal balloon 808 may comprise any of the balloon shapes describedherein. The distal balloon 808 may for example comprise a rigid toroidalballoon. The distal balloon 808 may be inflated to seal the bladderneck. Alternatively or in combination, the distal balloon 808 may act asan anchor at the bladder neck in order to prevent unintentional movementand/or removal of the inflatable balloon assembly. The proximal balloon806 may comprise a compliant material or a non-compliant material asdescribed herein. The proximal balloon 806 may be inflated to apre-determined pressure, shape, or volume as described herein. Theproximal balloon 806 may for example be inflated so as to re-approximatetissue to the organ wall and/or provide designed, direct compression onsurface vessel within the tissue to establish hemostasis.

FIGS. 25A-25F show a catheter with inflatable balloon assembly shaped toprovide compression hemostasis and avoid or reduce compression of selectregions or areas of the prostatic capsule or resection cavity, such asthe verumontanum. The inflatable balloon assembly may be substantiallysimilar to any of the inflatable balloon assemblies described herein.For example, this or any of the other inflatable balloon assembliesdescribed herein may comprise a proximal balloon and a distal balloon influid communication with one another. The inflatable balloon assemblymay comprise a single continuous balloon having an expandable distalportion and an expandable proximal portion which may correspond to thedistal balloon and proximal balloon of dual balloon assemblies. Theinflatable balloon assembly may comprise a proximal balloon, a distalballoon, or both as in any of the embodiments described herein. Theinflatable balloon assembly of this or any embodiment described hereinmay be shaped so as to selectively direct compressive contact with thetissue to specific regions of the tissue. The inflatable balloonassembly may, for example, be shaped to minimize or reduce contactbetween one or more expanded balloons of the inflatable balloon assemblyand the verumontanum of the prostate such as in order to protect thesexual function of the patient. The inflatable balloon assembly may beconfigured to provide hemostasis and/or re-approximate the remainingprostatic tissue (for example after tissue resection and cavityformation with a known shape profile as described herein). For example,in some instances it may be beneficial to avoid compressing or reducecontact with the region comprising the verumontanum as compression maycause adhesion of and closing of the seminal ducts, thus affectingsexual function of the patient. The inflatable balloon assembly may beshaped to apply outward compression on the internal cavity of theprostatic capsule without displacing or with minimal contact to theverumontanum. The inflatable balloon assembly may be shaped so as toapply non-uniform force circumferentially around the balloon in order toprovide reduced or decreased contact or pressure of the balloon with theverumontanum. The inflatable balloon assembly may for example be shapedwith a non-uniform cross-sectional circumference. Contact between theinflatable balloon assembly and the verumontanum may thus be decreasedwhen the inflatable balloon assembly is fully expanded.

FIG. 25A shows an inflatable balloon assembly comprising an expandableprostatic balloon 806 in a low-profile delivery configuration. Theexpandable prostatic balloon 806 may be a compliant balloon configuredto inflate to a pre-determined target pressure, shape, or volume andprovide direct compression and hemostasis control to a portion of thetissue within the prostatic capsule while avoiding or reducingcompression of sensitive tissue near or at the verumontanum. A proximalportion 8061 of the expandable prostatic balloon 806 may for example beadhered to the catheter to cause the balloon to “tent” over a regioncomprising the verumontanum when expanded and thereby preventcompression of the tissues within the verumontanum region.

FIG. 25B shows a top-view of an inflatable balloon assembly comprise anexpandable prostatic balloon 806 in a low-profile deliveryconfiguration. The expandable prostatic balloon 806 may comprise one ormore wires 8062, for example, two or three wires. The wires may bedeployed against the surface of the balloon near the verumontanum so asto guide the balloon to form a tenting structure or concavity over theverumontanum. The wires may be freely moving against the balloon or maybe strategically adhered to the balloon. The wires may be located eitherinside the balloon or outside the balloon. The wires may comprise arigid, semi-rigid, or shape-memory material. The wires may, for example,comprise nitinol or spring steel which may readily move from a lowprofile configuration during delivery to an expanded, shapedconfiguration when deployed in the prostatic capsule 900.

FIG. 25C shows a front-view of an expanded inflatable balloon assemblycomprising a prostatic balloon 806 shaped to avoid compressing or reducecontact with the verumontanum. FIG. 25F shows a side-view of theexpanded inflatable balloon assembly shaped to avoid or reduce contactwith the verumontanum. The inflatable balloon assembly may optionallyfurther comprise an expandable bladder balloon 806 which may compressthe bladder neck and/or act as an anchor for the device as describedherein. The inflated prostatic balloon 806 may be shaped by anycombination or wires or adherence to the catheter so as to for a concaveor tent region over the verumontanum V. Alternatively or in combination,the thickness and/or compliance of the prostatic balloon wall(s) may bevaried so as to enable shaped and/or sequential expansion of the balloonas described herein. For example, a distal portion of the balloon (forexample at or near line A-A, the cross-section of which is shown in FIG.25D) may comprise a uniform thickness and/or compliance such that theentire balloon expands at or nearly at the same time. A proximal portionof the balloon (for example, at or near line B-B, the cross-section ofwhich is shown in FIG. 25E) may comprise an non-uniform thickness and/orcompliance, with a region of increased thickness or rigidity disposednear the approximate location of the verumontanum V, such that theregion of the balloon near the verumontanum V expands after the morecompliant portion 2202 of the balloon, or does not expand substantiallyat all, thereby generating the desired concave tent structure over theverumontanum V. The prostatic balloon material may comprise a variablethickness in order to cause progressive or sequentially inflation of theballoon and create a sweeping motion toward the verumontanum, leavingthe balloon pinched and pulled centrally to form the tent-like structureover the verumontanum.

Alternatively or in combination, the prostatic balloon may be molded orshaped to comprise a concavity or wedge/tent-like region so as to avoidcontacting or reduce contact with the verumontanum.

In this or any single-balloon embodiment described, it will beunderstood that the terms “proximal” and “distal” may be usedinterchangeably as the use of the terms in dual-balloon embodimentsdenote the relative position of the two balloons to each other. Forexample, the expandable prostatic balloon shown here may be referred toas a distal balloon. If an expandable bladder balloon were added (asshown in FIG. 25C), the bladder balloon, being located distal to theprostatic balloon, may be referred to as a distal balloon while theprostatic balloon may be referred to as a proximal balloon. It will beunderstood by one of ordinary skill in the art that any of theembodiments described herein may be modified to add or remove balloonsand thus the relative terminology used to describe the final inflatableballoon assembly configuration may be altered as described hereinwithout altering the desired properties of the balloon.

In at least some instances, it may be beneficial to provide acompression in combination with delivery of a hemostatic agent in orderto reach hemostasis within the tissue. Any of the embodiments describedherein to deliver a hemostatic agent to a tissue space may be configuredwith a shape, volume, or pressure configured to contact and compress thetissue as described herein. Any of the embodiments described herein toprovide compression to the tissue may be configured to deliver ahemostatic agent to the tissue as described herein (for example througha delivery port(s) on the catheter, through pores on one or moreballoon, by coating one or more balloon with a hemostatic agent, mesh,or scaffold, etc.). It will be understood by one of ordinary skill inthe art that many of the features described herein are optional and/orinterchangeable so as to achieve the desired hemostatic results. Forexample, any of the balloons or inflatable balloon assemblies describedherein may be coated with a hemostatic agent such that compressing theballoon into the tissue also compresses the hemostatic agent into thetissue. Combining compression and hemostatic agent delivery may speed uphemostasis and/or provide hemostasis to non-uniform tissue geometriesmore readily.

In at least some instances, it may be beneficial to modify thehemostatic device so as to prevent migration of the catheter afterplacement. Any of the embodiments described herein may comprise one ormore features configured to minimize or prevent catheter migration.

FIG. 26 shows an exemplary embodiment of an inflatable balloon assemblycomprising a urethral bulb 818 to minimize catheter migration. Theinflatable balloon assembly may comprise a proximal balloon, a distalballoon, a single balloon with proximal and distal portions, or anycombination thereof. As shown here, the inflatable balloon assembly mayfor example comprise a distal balloon 808 situated at or near thebladder neck and a proximal balloon 806 at least partially locatedwithin the prostatic capsule as described herein. The inflatable balloonassembly may further comprise a bulb 818 positioned on the catheterproximal of the inflatable balloon assembly. The bulb 818 may beconfigured to be positioned in the ureter when the inflatable balloonassembly is positioned in the prostatic capsule so as to minimizemigration of the catheter. The bulb 818 may be expandable or inflatable,for example a balloon. The bulb 818 may alternatively be rigid, forexample a tab. The bulb 818 may for example be expanded or inflatedafter the catheter has been placed in a desired location as describedherein. The bulb may alternatively or in combination be configured tomaintain tension on the catheter and inflatable balloon assembly inorder to promote hemostasis.

The tension on the catheter may be maintained with a range of about 0.1to about 1.4 kg in order to promote hemostasis as described herein.

Alternatively or in combination, the catheter may be coupled to anenclosure adapted to resist repositioning and maintain a position of abodily member as shown in FIGS. 27B-27C. The enclosure may for examplebe a flexible enclosure as shown or an inflexible enclosure. Theenclosure may be configured to conform to a bodily member. The flexibleenclosure may be adapted to enclose the bodily member. The enclosure maycomprise a material with a thickness and/or elasticity sized to fit overa bodily member and hold the bodily member in place. The enclosure maycomprise a soft, compliant, and/or stretchable material configured todecrease irritation of the bodily member. The catheter may be at leastpartially positioned with in the bodily member. The flexible enclosuremay be shaped to conform to and apply pressure to the bodily member toresist repositioning of the flexible enclosure when enclosing the bodilymember. The distal tip of the flexible enclosure may be configured tocouple to the catheter. The distal tip of the flexible enclosure may beconfigured to couple to a retainer element. The retainer element may becoupled to a proximal segment of the catheter extending out of thebodily member. The enclosure may be configured to be coupled to asegment of the catheter extending out of the bodily member through aretainer element coupled to the segment. The bodily member may forexample comprise a penis and the catheter may extend out of an urethralos. The flexible enclosure may be configured to be concentric with aurethra of the penis when enclosing the penis.

FIG. 27A shows a section view of a bodily member prior to positioningwith a flexible enclosure. The bodily member may for example comprise apenis. The urethra is the tube connecting the bladder B to the urethralos 50 through the prostatic capsule 900, external sphincter 56, andpenis 54. When the penis 54 is flaccid as shown, the urethra maycomprise may twists and or turns which cause the urethra, prostaticcapsule 900, and urethral os 50 are out of alignment. The penis 54 maybe positioned described herein to align the urethra with the prostaticcapsule 900 so as to prevent movement of the catheter due to movement ofthe penis 54.

FIG. 27B shows an exemplary embodiment of a catheter 2200 coupled to aflexible enclosure 819 enclosing a penis. The catheter 2200 may compriseany of the catheters and/or any of the balloons, inflatable balloonassemblies, or expandable elements described herein. The catheter 2200may for example comprise a distal balloon 808 and a proximal balloon 806as described herein. The flexible enclosure 819 may be at leastpartially cylindrical in shape. The flexible element may comprise asoft, compliant material to minimize irritation against tissue of thepenis. The flexible element may, for example, comprise a penis guard orcover 820. The flexible enclosure 819 may comprise a retainer element821 coupled to a proximal, external segment of the catheter 2200. Theflexible enclosure 819 may be configured to be coupled to a pelvic orgroin mount 822 to maintain the position of the flexible enclosure 819and enclosed penis. For example, the pelvic or groin mount 822 may beconfigured to pull on the flexible enclosure 819 and the enclosed penisin order to align the urethra with the urethral sphincter such that thehemostatic device (comprising a catheter) is relatively straight withinthe tissue. The pelvic or groin mount 822 may provide a surface areawhich presses equally or nearly equally on the pubic region and theperineum. The pelvic or groin mount 822 may provide event comfort whendocked on a bony structure, sat upon, or belted on in order to preventrotation or loss of position of the flexible enclosure 819. The pelvicor groin mount 822 may enclose and grip onto the base of the penis andthe scrotum such that the anatomy is pulled down to align the urethrawith the prostate (and bladder os). The catheter may be retained in thetissue due to tension between the catheter and the balloons. A distalportion of the catheter may be coupled to one or more balloons and anexternal proximal portion of the catheter may be secured to the retainerelement. The catheter between the one or more balloons and the retainerelement may comprise a tension. The pelvic or groin mount 822 may becoupled to the groin or hip bones to counter the tension in the catheterand fixate the catheter (and thus the retainer element and flexibleelement in tension.

The device may further comprise a tension or traction element configuredto couple to one or more of the catheter or the flexible enclosure toalign the urethra with the urethral sphincter. The catheter may, forexample, be drawn through the retainer element of the flexible enclosureand attached to the tension element. In some instances, it may bebeneficial to provide direct therapeutic tension to compress a bleedingtissue in order to achieve hemostasis or to maintain the position of thecatheter and/or expandable elements within the tissue. Application oftension may be provided in combination with any of the mechanisms formaintaining catheter position described herein.

FIG. 27C shows a saddle traction device configured to maintain theposition of the catheter 2200 as well as provide tension to the catheterand/or balloons. The device may, for example, comprise a flexibleenclosure 819 substantially similar to that of FIG. 27B. The device maycomprise a flexible enclosure 819 coupled to the catheter 2200, thecatheter comprising a proximal balloon 806 within the prostatic capsule.The catheter may alternatively or in combination comprise a distalbladder balloon as described herein (not shown).

The device may further comprise a tension or traction element configuredto couple to one or more of the catheter or the flexible enclosure toalign the urethra with the urethral sphincter. The catheter may, forexample, be drawn through the retainer element of the flexible enclosureand attached to the tension element. In some instances, the retainerelement may comprise a tension element and may provide tension as wellas position maintenance for the catheter. One or more of the scrotum orpenis may be moved to accommodate the tension element. The tensionelement may apply tension collinearly with the catheter shaft throughthe sphincter. The tension element may apply tension with the balloonexpanded within the tissue space. The expanded balloon(s) may counteractthe tension applied to the catheter so as to maintain the position ofthe catheter within the tissue space. The tension may be appliedconcentrically in order to avoid or reduce trauma or ischemia to thetissue or surrounds of the sphincter. Movement of the sphincter may beevenly distributed due to the concentric tension.

Alternatively or in combination, the tension element may comprise apre-selected weight coupled to a proximal portion of the catheter. FIG.27D shows an exemplary hospital bed-mounted hemostatic device comprisinga pre-selected weight tension element 840 coupled to a proximal portionof the catheter 2200. The pre-selected weight 840 may for examplecomprise a fluid container (e.g. a bag, flask, or the like) configuredto hold a pre-selected volume of fluid (e.g. water). The pre-selectedweight 840 may for example comprise a pre-selected calibrated weight asknown to one of ordinary skill in the art. Alternatively or incombination, the tension element 840 may comprise a calibrated springdevice. A calibrated spring device tension element may for example beadjusted by threading or ratcheting to provide a pre-determined amountof tensile force. The catheter 2200 and/or the tension device 840 may beattached to hospital stirrups or a hospital bed frame 830. Attachment tosuch a low friction device may allow gravity to act directly on theanchor to provide tension to the catheter and/or balloon(s).Alternatively or in combination, attachment to a hospital bed frame, forexample, may allow the angle of tension to be adjusted so as to pull thecatheter collinearly to the urethra U and avoid or reduce pressureagainst the sphincter wall 56. The amount of tension and/or thepre-selected weight of the tension element may be selected in responseto a measured blood pressure as described herein. For example, theweight of the tension element may be selected to provide a pressure tothe balloons which is slightly above the measured blood pressure so asto promote hemostasis and avoid or reduce complications which may arisefrom applying more or less compression to the tissue as describedherein. Optionally, the device may further comprise a tensionmeasurement element or scale configured to couple to the tension elementso as to measure the tension applied by the tension element.

FIG. 28 shows a schematic of a sealant delivery device comprising aprocessor. The sealant delivery device may comprise any of theembodiments described herein. The sealant delivery device may forexample comprise one or more expandable members 2803 or expandablesupports as described herein. The expandable member 2803 may beconfigured to apply compression to the internal surface of the bleedingtissue space as described herein. The expandable member 2803 may beoperably coupled to a processor 2801. The processor 2801 may beconfigured to receive a blood pressure of the subject and controlexpansion of the expandable member 2803 in response to the receivedblood pressure. The blood pressure of the patient may for example beinput manually by the operator or may be received from a blood pressuresensor 2802. The processor 2801 may be configured to control expansionof the expandable member 2803 such that the expandable member isexpanded o an internal pressure greater than the received blood pressureof the subject in order to apply compression to the tissue. Theexpandable member 2803 may exert a pressure on the tissue that is abovethe received blood pressure of the subject. The pressure exerted on thetissue may for example be measured using a pressure sensor.Alternatively or in combination, the internal pressure of the expandablemember 2803 may be measured by a pressure sensor fluidly coupled to theexpandable member 2803. The pressure sensor may comprise any pressuresensor as known to one of ordinary skill in the art. The processor maybe coupled to the pressure sensor and configured to measure a firstinternal pressure of the expandable member 2803. The processor may thencause the expandable member 2803 to expand to a second internal pressuregreater than the blood pressure of the subject in response to thereceived blood pressure. The processor 2801 may for example be coupledto a controller 2804 which is configured to control inflation of theexpandable member 2803. Alternatively or in combination, the processormay comprise a controller to control inflation of the expandable member2803. The processor 2801 may be coupled to a display 2805 in order todisplay one or more of the received blood pressure, the first measuredinternal pressure of the expandable member 2803, or the measuredinternal pressure of the expandable member 2803 after adjustinginflation in response to the received blood pressure. Any of the sealantdelivery device embodiments described herein may comprise a pressuresensor and/or be coupled to a processor.

FIG. 29 shows a catheter comprising distance markers to monitor cathetermigration. In addition to or as an alternative to providing a featureconfigured to minimize or prevent migration of the catheter within thetissue, it may be beneficial to directly monitor catheter position orlocation. In any of the embodiments described herein, the catheter 2200may further comprise one or more indicia 817 positioned on an outersurface of a proximal portion of the catheter 2200 when the catheter hasbeen advanced into the tissue space of interest, for example theprostatic capsule 900. The indicia 817 may comprise one or more bandspositioned on the outer surface of the proximal portion of the catheterfor example. The indicia 817 may for example comprise user-perceptibleindicia. The location of the catheter may be determined in response to avisual or tactile inspection of the one or more indicia 817. The indicia817 may be located in a band or region that is adjustable so as toaccount for the compressibility of the penis. The indicia 817 may beused to monitor catheter migration and/or orientation. For example, theembodiment of FIG. 25A may comprise one or more indicia 817 disposed ona proximal portion of the catheter as shown to indicate the angularorientation of the catheter with reference to the tent structure overthe verumontanum in order to ensure correct positioning and reducedcontact of the expandable support or inflatable balloon assembly withthe verumontanum.

In any of the embodiments described herein, the proximal balloon, distalballoon, both balloons, or any of the inflatable balloon assembliesdescribed herein may comprise one or more pre-determined sizes. In anyof the embodiments described herein, the proximal balloon, distalballoon, both the proximal and distal balloons, or any of the inflatableballoon assemblies may comprise a non-uniform thickness or compliance inorder to provide stepwise expansion.

In any of the embodiments described herein, the proximal balloon, distalballoon, both balloons, or any of the inflatable balloon assembliesdescribed herein may comprise a compliant material, non-compliantmaterial, or a combination of materials. One or more balloons may have auniform compliance or a non-uniform compliance. The compliance of theone or more balloons may be chosen by one of ordinary skill in the artto match the hemostasis requirements of the tissue.

One or more balloon may comprise a non-compliant material so as to besubstantially rigid. A rigid balloon may be configured so as to comprisea specific volume and/or volume when inflated. It will be understood byone of ordinary skill in the art that the rigid balloon may beconfigured with any volume or shape desired.

One or more balloon may comprise a compliant material. A compliantballoon may comprise a very compliant material, a moderately compliantmaterial, or any combination thereof.

A very compliant material may for example permit stretching of a balloonduring inflation in any direction in the absence of tissue or fluidpressure resistance. Inflation of a very compliant balloon may becontrolled by configuring the balloon with a pre-determined internalvolume such that the balloon conforms to the tissue cavity and becomesintimate with the cavity wall tissue equally. Alternatively or incombination, inflation of a very compliant balloon may be controlled byinflating the balloon to a pre-determined target pressure in an enclosedtissue space.

In any of the embodiments described herein, the proximal balloon, distalballoon, both the proximal and distal balloons, or any of the inflatableballoon assemblies described herein may be expanded to a targetpressure. The target pressure for the proximal balloon may differ fromor be the same as the target pressure for the distal balloon. The targetpressure may be applied against the prostate, for example uniformlyalong the cavity wall and openings or at one or more locations withinthe prostatic capsule. The target pressure may be any pressure desiredby one of ordinary skill in the art. The target pressure may for examplebe determined in response to a blood pressure of a patient in order toapply just enough pressure to inhibit bleeding through directcompression by the balloon. For example, the target pressure at theterminus of a distal balloon at a bleeding bladder neck (or distalopening) or of a proximal balloon at the peripheral/external sphincter(or proximal opening) may be selected to be slightly higher than theblood pressure of the patient so as to inhibit bleeding throughcompression. The blood pressure of the patient may be measured prior toinflation of the balloon in order that the target pressure may bedetermined for the measured blood pressure.

A moderately compliant material may for example permit stretching of aballoon during inflation with the dominant distension force (coming fromwithin the balloon via fluid pressure) greater than typical bodypressures and tissue flexibility so as to resist conformation to theshape of the cavity. The shape of a moderately compliant balloon may beconfigured to as to allow for post-procedural guidance of tissue shapeduring initial tissue approximation healing. The size and shape of theballoon may be selected based on the volume of resected tissue and/oroptimized to mimic the anatomic shape of the tissue cavity post-healing.

In any of the embodiments described herein, the proximal balloon, distalballoon, both balloons, or any of the inflatable balloon assembliesdescribed herein may be coupled to an external pressure indicator inorder to monitor the pressure of the balloon(s) or assemblies. Theexternal pressure indicator may for example be configured to indicate toa user when the balloon(s) or assemblies have reached a target pressure.The external pressure indicator may for example comprise an externalcalibrated balloon and/or a gravity pressure device such as a manometer.An external calibrated balloon may for example be coupled to theconfigured to begin expanding at a target pressure, for example at thetarget pressure of one or more balloons of the hemostatic device.Alternatively or in combination, the external calibrated balloon may beconfigured with multiple calibrated elongation thresholds which providestepped expansion as the pressure increases in order to indicatemultiple target pressures being reached. Stepped expansion may forexample occur if the calibrated balloon comprises stepped thicknessesand/or compliances such that the thicker or less compliant portions ofthe balloon are stretched successively following the thinner portions ofthe balloon reaching their elongation limit(s).

In any of the embodiments described herein, the proximal balloon, distalballoon, both the proximal and distal balloons, or any of the inflatableballoon assemblies described herein may comprise a material tofacilitate imaging of the sealant delivery device. In some cases, it maybe desirable to image the sealant delivery device to determine theposition or location of the device within the tissue during delivery,prior to balloon inflation, during sealant delivery, and/or afterballoon deflation. One or more balloon may comprise an ultrasoundhyperechoic material to aid visualization with TRUS or other ultrasoundtechnology. Alternatively or in combination, one or more balloon maycomprise a radiopaque material such as tantalum or gold to aidvisualization with x-ray imaging technologies. Alternatively or incombination, one or more balloon may be coupled to one or moreradiopaque markers for visualization.

In any of the embodiments described herein, the proximal balloon, distalballoon, both balloons, or any of the inflatable balloon assembliesdescribed herein may comprise a uniform thickness or a non-uniformthickness. The thickness of the one or more balloons may be controlledin order to allow for timed or sequential inflation of the balloonsand/or direction- or shape-controlled inflation of the balloons. Thethickness of the one or more balloons may be configured so as to providethe one or more balloons with a pre-determined shape(s).

In any of the embodiments described herein, the proximal balloon, distalballoon, both the proximal and distal balloons, or any of the inflatableballoon assemblies described herein may comprise a pre-determined shape.One or more balloons may have a pre-determined shape that is spherical(e.g., with the balloon attached to the catheter at two points chosensuch that the balloon inflates spherically), toroidal (e.g., with theballoon attached to the catheter at a single point such that the ballooninflates toroidally around the catheter shaft), cylindrical (e.g., withthe balloon attached to the catheter at two distant points such that theballoon inflates in an elongated cylinder), or any shape desired (e.g.,a non-compliant balloon may be molded with a distended shape or aballoon may have varying regions of compliance to reach the desiredshape upon inflation), or any combination thereof. The pre-determinedshape may be a dumbbell shape as described herein.

In any of the embodiments described herein, both the proximal and distalballoons, or any of the inflatable balloon assemblies described hereinmay comprise a textured outer surface. The outer surface of one or moreballoons may for example comprise ribbing, dimpling, chevrons,concentric rings, and/or elements of progressive changing dimension inorder to control positioning, migration, expansion order, and/orprogression of the balloons. The one or more balloons may, for example,be substantially smooth when deflated and textured when inflated to helphold the sealant delivery device in place within the tissue cavity. Theentire outer surface or a portion of the outer surface of the one ormore balloons may be textured.

One or more balloons may comprise a variety of materials, a variety ofthicknesses, a variety of textures, a variety of shapes, or anycombination thereof in order to reach the desired hemostatic control.

Any of the embodiments disclosed herein may further comprise an externalpressure indicator. The external pressure indicator may, for example,comprise an external calibrated balloon. The balloon may be calibratedwith elongation thresholds in order to provide stepped expansion andpressure indications. For example, the balloon may comprise one or morethicker portions and one or more thinner portions. Stepped expansion maybe achieved by first expanding the thinner portions to an elongationthreshold or limit then successively stretching the thicker portionswhich may be configured to resist expansion while the thinner portionsare below their elongation threshold. Alternatively or in combination,the external pressure indicator may comprise a gravity pressureindicator device, for example a monometer.

Any of the embodiments described herein may comprise a mesh disposedover one or more balloons, inflatable balloon assemblies, or expandablemembers. Expansion of the mesh-covered member(s) may comprise pressingthe mesh against the tissue as described herein. The mesh may remain inthe tissue space for a time after the member(s) have been removed or maybe removed with the member(s). For example, expanding a distal balloonmay comprise pressing a mesh disposed over the distal balloon againstthe tissue. The distal balloon may be collapsed and retracted from thetissue space along with the catheter while the mesh is left in thetissue space. The mesh may then be later removed or may comprise amaterial that is at least partially bioabsorbable or resorbable suchthat it is degraded or absorbed by the tissue over time. The mesh mayalternatively be permanently implantable. The mesh may be coated with ahemostatic agent, for example a clot promoting agent like fibrin orthrombin.

Any of the embodiments described herein may comprise a scaffold disposedover one or more balloons, inflatable balloon assemblies, or expandablemembers. Expansion of the scaffold-covered member(s) may comprisepressing the scaffold against the tissue as described herein. Thescaffold may remain in the tissue space for a time after the member(s)have been removed or may be removed with the member(s). For example,expanding a distal balloon may comprise pressing a scaffold disposedover the distal balloon against the tissue. The distal balloon may becollapsed and retracted from the tissue space along with the catheterwhile the scaffold is left in the tissue space. The scaffold may then belater removed from the tissue space after a time delay, for examplebetween about 1 to about 3 days. The scaffold may for example comprise asilicone shaped stent configured to maintain shape and protect theverumontanum.

Any of the embodiments described herein may comprise one or moreballoons, inflatable balloon assemblies, or expandable memberscomprising one or more pores. Any of the embodiments described hereinmay comprise a plurality of pores. The one or more pores may beconfigured to deliver a hemostatic agent to the tissue. Alternatively orin combination, the one or more pores may configured to deliver atherapeutic agent to the tissue, for example, a chemotherapeutic agentor any therapeutic agent known to one of ordinary skill in the art. Forexample, a distal balloon may comprise a plurality of pores throughwhich a therapeutic agent may be delivered into the space between theexpanded distal balloon and an internal surface of the tissue. Deliveryof the hemostatic agent and/or therapeutic agent may occur with avariety of shape profiles, time constants, and/or penetrations followingtissue resection for example. It will be apparent to one of ordinaryskill in the art that delivery of the hemostatic and/or therapeuticagents may be altered depending on the material being delivered and thedesired delivery pattern, timing, and/or other delivery characteristics.

Referring to FIGS. 30A-41D, various saddle traction devices forenclosing an anatomical member, such as a penis, and a catheter, such asa Foley catheter or the hemostatic catheter 2200 described herein,extending therefrom are described. The saddle traction devices may beconfigured to couple to the catheter and rest against the pelvic area ofa patient to align the urethra with the urethral sphincter. The saddletraction devices may further apply tension to the coupled catheter. Insome instances, it may be beneficial to provide direct therapeutictension to compress a bleeding tissue in order to achieve hemostasis orto maintain the position of the catheter and/or expandable elementswithin the tissue. The application of tension may be provided incombination with any of the mechanisms for maintaining catheter positiondescribed herein.

FIGS. 30A, 30B, 30C, and 30D show a saddle traction device 3000. Thesaddle traction device 3000 may comprise a pelvic or groin mount or base3010, which may provide a surface area which presses equally or nearlyequally on the pubic region and the perineum. The pelvic or groin mount3010 may provide event comfort when docked on a bony structure, satupon, or belted on in order to prevent rotation or loss of position ofthe flexible enclosure 3010. The pelvic or groin mount 3010 may encloseand grip onto the base of the penis and the scrotum such that theanatomy is pulled down to align the urethra with the prostate (andbladder os).

The saddle traction device 3000 may further comprise a retainer element3020 through which a catheter, such as a Foley catheter or the catheter2200 may be fixedly attached, and a plurality of extension struts 3030extending from the base 3020 to couple to the retainer element 3030. Theextension struts 3030 may be coupled to the base 3020 through hinges3040, for example, living hinges, such that the saddle traction device3000 may be collapsed for easier storage and transportation. In anon-collapsed configuration, the base 3010 and the extension struts 3030together define an opening or a concavity through with one or moreanatomical members, such as the penis and the scrotum, can extend into.As shown in FIGS. 30A-30D, the extension struts 3040 may be relativelystraight and may be arranged to form a tripod. The extension struts 3040may instead be rounded so that the saddle traction device 3000 mayprovide greater internal clearance to accommodate larger anatomies.Also, greater numbers of extension struts 3040 may be provided, forexample, four or more to form a pyramid. The retainer element 3020 maycomprise a series of internal threads, teeth, or other friction elementsto facilitate attachment with the catheter through frictionalinterference. The base 3010 may have an opening 3010 a through which thecatheter can pass as the saddle traction device 3000 is mounted over theone or more anatomical members.

As described herein, a tension or traction element may be provided tocouple to the catheter or the flexible enclosure to align the urethrawith the urethral sphincter. The catheter may, for example, be drawnthrough the retainer element 3040 and attached to the tension element.In some embodiments, the tension may be applied simply be tensioning thecatheter to apply a predetermined and/or user-desired amount of forcebefore fixing the catheter on the retainer element 3030. A user-desiredamount of force can be provided by lengthening the catheter by a strokelength, such as between about 1 cm to about 8 cm, or about 2 cm to about5 cm, to apply tension. The force or tension applied may be constantover a significant range of the stroke length, such as 50% over thestroke length range, so that the force or tension applied to the anatomycan be known and maintained at safe and optimal levels. Alternatively orin combination, the catheter may be coupled to a constant force springto apply tension as described herein. In some instances, it may bebeneficial to provide direct therapeutic tension with the saddletraction device 3000 to compress a bleeding tissue in order to achievehemostasis or to maintain the position of the catheter and/or expandableelements within the tissue. For example, the saddle traction device 3000may be applied for 2-4 hours after a procedure to achieve hemostasis.Application of tension may be provided in combination with any of themechanisms for maintaining catheter position described herein.

FIGS. 31A, 31B, 31C, and 31D show a saddle traction device 3100 whichmay be similar to the saddle traction device 3000 and other describedherein. The saddle traction device 3100 may comprise a pelvic or groinmount or base 3110 having an opening 3110 a to allow a catheter to passthrough, a retainer element 3120, and a plurality of extension struts3130 extending from the base 3110 and coupled thereto with hinges 3140to couple to the retainer element 3120. The extension struts 3130 may berounded. The retainer element 3120 may be similar to the retainerelement 3020 and may be configured to fix to a catheter with frictionalinterference. The retainer element 3120 may comprise first and secondsides which may be snapped or closed together to capture the catheter2200. The hinges 3140 may comprise living hinges or pinned hinges. Thesaddle traction device 3100 may be manufactured as a single piece,integral device (such as in cases where the hinges 3140 are livinghinges), and may be collapsed to a flat configuration. In some cases,the penis may be positioned adjacent the opening 3110 a and the scrotummay be positioned diametrically opposed to the opening 3110 a. In othercases, the scrotum may be positioned adjacent the opening 3110 a and thepenis may be positioned diametrically opposed to the opening 3110 a.

FIGS. 32A, 32B, 32C, and 32D show a saddle traction device 3200 whichmay be similar to any of the saddle traction devices 3100, 3000 andother described herein. The saddle traction device 3200 may comprise apelvic or groin mount or base 3210 having an opening 3210 a to allow acatheter 2200 to pass through, a retainer element 3220, and a pluralityof extension struts 3230 extending from the base 3210 and coupledthereto with hinges 3240 to couple to the retainer element 3220.

FIG. 33 shows the catheter 2200 with medical tape adhered thereon toprovide a flag 3300 which may be used to assist with coupling thecatheter 2200 with the retainer element 3220. Alternatively or inaddition to providing frictional interference, the retainer element 3220may comprise a clamp configured to be closed onto the flag 3300 providedon the catheter 2200. In some cases, it may be desirable for theretainer element to couple to the flag 3300 rather than the catheter2200 itself to reduce a risk of interrupting or obstructing fluid flowthrough the catheter 2200, for example, if the fit between the retainerelement and catheter 2200 is too tight. A latch may be provided to theretainer element 3220 to allow the retainer element 3220 to open andclose.

FIGS. 34A, 34B, 34C, and 34D show a saddle traction device 3400 whichmay be similar to any of the saddle traction devices 3200, 3100, 3000,and other described herein. The saddle traction device 3400 may comprisea pelvic or groin mount or base 3410 having an opening 3410 a to allow acatheter 2200 to pass through, a retainer element 3420, a firstextension strut 3430 a extending from the base 3210 and coupled theretowith a hinge 3440 to couple to the retainer element 3420, a secondextension strut 3430 b extending from the base 3210 and coupled theretowith a hinge 3440 to couple to the retainer element 3220, a firstcross-member 3435 a connecting the first and second extension struts3430 a, 3430 b to one another, and a second cross-member 3435 bconnecting the first and second extension struts 3430 a, 3430 b to oneanother. The saddle traction device 3400 may further comprise anexternal spring 3432 coupled to the first extension strut 3430 a and theretainer element 3440. The retainer element 3440 can be moved along thefirst and second extension struts 3430 a, 3430 b to apply or releasetension to the catheter 2200 when it is coupled thereto. For instance,the ends of the cross-member of the retainer element 3440 may bereleasably clamped to the first and second extension struts 3430 a, 3430b. The spring 3432, in many cases, may apply the tension. The saddletraction device 3400 may further comprise a scale 3434 coupled to thesecond extension strut 3430 b such that the amount of tension appliedcan be indicated.

FIGS. 35A, 35B, 35C, and 35D show a saddle traction device 3500 whichmay be similar to any of the saddle traction devices 3400, 3200, 3100,3000 and other described herein. The saddle traction device 3500 maycomprise a pelvic or groin mount or base 3510 having an opening 3510 ato allow a catheter 2200 to pass through, a retainer element 3520, afirst extension strut 3530 a extending from the base 3510 and coupledthereto with a hinge 3540 to couple to the retainer element 3520, asecond extension strut 3530 b extending from the base 3510 and coupledthereto with a hinge 3540 to couple to the retainer element 3520, and across-member 3535 connecting the first and second extension struts 3530a, 3530 b to one another. The saddle traction device 3500 may furthercomprise a telescoping, infinitely adjustable tensioning mechanism 3545coupled to the second extension strut 3530 b and the retainer element3540 to adjustably apply tension to the retainer element 3540 and thecatheter 2200 to be coupled thereto. For example, the amount of tensionapplied may be adjusted by adjusting a washer 3545 w on the tensioningmechanism 3545. The tensioning mechanism 3545 may include an indicatorfor the amount of tension applied. For example, the indicator mayindicate amounts of tension in gradations between 0 to 1.4 kg.

FIGS. 36A, 36B, 36C, and 36D show a saddle traction device 3600 whichmay be similar to any of the saddle traction devices 3500, 3400, 3200,3100, 3000 and other described herein. The saddle traction device 3600may comprise a pelvic or groin mount or base 3610 with an increasedcross-section compared to the base 3510, a retainer element 3620, afirst extension strut 3630 a extending from the base 3610 and coupledthereto with a rigid coupling 3640 to couple to the retainer element3620, a second extension strut 3630 b extending from the base 3610 andcoupled thereto with a rigid coupling 3640 to couple to the retainerelement 3620, and a cross-member 3635 connecting the first and secondextension struts 3630 a, 3630 b to one another. The first and secondextension struts 3630 a, 3630 b may be coupled to curved extensionportions of the base 3610 such that the couplings 3640 are positionedaway from the main body of the base 3610, allowing additional clearancefor the patient's anatomy. The rigid couplings 3640 may providestructural support for the extension struts 3630 a, 3630 b so thattension applied does not inadvertently deform the saddle traction device3600. The saddle traction device 3600 may further comprise atelescoping, infinitely adjustable tensioning mechanism 3645 coupled tothe second extension strut 3630 b and the retainer element 3640.

FIGS. 37A, 37B, 37C, and 37D show a saddle traction device 3700 whichmay be similar to any of the saddle traction devices 3600, 3500, 3400,3200, 3100, 3000 and other described herein. The saddle traction device3700 may comprise a pelvic or groin mount or base 3710, a retainerelement 3720, a first extension strut 3730 a extending from the base3710 and coupled thereto with an adjustable hinge 3740 to couple to theretainer element 3720, a second extension strut 3730 b extending fromthe base 3710 and coupled thereto with an adjustable hinge 3740 tocouple to the retainer element 3720, and a cross-member 3735 connectingthe first and second extension struts 3730 a, 3730 b to one another. Theportions of the first and second extension struts 3730 a, 3730 b coupledto the base 3710 may be curved away from the longitudinal axes of theirrespective extension strut to allow additional clearance for thepatient's anatomy. The adjustable hinges 3740 may allow the angle of theextension struts 3730 a, 3730 b to be varied so that the angle at whichthe catheter 2200 is tensioned relative to the patient can be varied.The saddle traction device 3700 may further comprise a telescoping,infinitely adjustable tensioning mechanism 3745 coupled to the secondextension strut 3730 b and the retainer element 3740.

FIGS. 38A, 38B, 38C, 38D, and 38E show a saddle traction device 3800which may be similar to any of the saddle traction devices 3700, 3600,3500, 3400, 3200, 3100, 3000 and other described herein. The saddletraction device 3800 may comprise a pelvic or groin mount or base 3810,a retainer element 3820, a first extension strut 3830 a extending fromthe base 3810 and coupled thereto with an adjustable hinge 3840 tocouple to the retainer element 3820, a second extension strut 3830 bextending from the base 3810 and coupled thereto with an adjustablehinge 3840 to couple to the retainer element 3820, and a cross-member3835 connecting the first and second extension struts 3830 a, 3830 b toone another. The adjustable hinges 3840 may allow the angle of theextension struts 3830 a, 3830 b to be varied so that the angle at whichthe catheter is tensioned relative to the patient can be varied. FIG.38E shows a magnified view of the adjustment mechanism of the adjustablehinge 3840. The adjustment mechanism may comprise a spring 3840 a and areleasable coupling interface 3840 b. The second extension strut 3830 bmay be urged inward to be released from the releasable couplinginterface 3840 b so that the angle of the second extensions strut 3830 bcan be adjusted. Once the angle is adjusted as desired, the secondextension strut 3830 b may be released from the inward force such thatthe spring 3840 a can urge the second extension strut 3830 b back towardthe releasable coupling interface 3840 b to couple thereto. The saddletraction device 3800 may further comprise a telescoping, infinitelyadjustable tensioning mechanism 3845 coupled to the second extensionstrut 3830 b and the retainer element 3840.

FIGS. 39A, 39B, 39C, and 39D show a saddle traction device 3900 whichmay be similar to any of the saddle traction devices 3800, 3700, 3600,3500, 3400, 3200, 3100, 3000 and other described herein. The saddletraction device 3900 may comprise a pelvic or groin mount or base 3910having a base cross-member 3915, a retainer element 3920, a firstextension strut 3930 a extending from the base 3910 and coupled theretowith an adjustable hinge 3940 to couple to the retainer element 3920, asecond extension strut 3930 b extending from the base 3910 and coupledthereto with an adjustable hinge 3940 to couple to the retainer element3920, and a cross-member 3935 connecting the first and second extensionstruts 3930 a, 3930 b to one another. The portions of the first andsecond extension struts 3930 a, 3930 b coupled to the base 3910 may becurved away from the longitudinal axes of their respective extensionstrut to allow additional clearance for the patient's anatomy. The base3910 may be U-shaped with a large open side to improve access to therectum and provide scrotal comfort. The base cross-member 3915 mayprotrude away from the plane of the base 3910 to provide greaterclearance. The saddle traction device 3900 may further comprise atelescoping, infinitely adjustable tensioning mechanism 3945 coupled tothe second extension strut 3930 b and the retainer element 3940. Theretainer element 3940 may comprise a bracket-shaped cross-member tocouple to the first and second extension struts 3930 a, 3930 b such thatthe coupled catheter 2200 is offset from the plane of the first andsecond extension struts 3930 a, 3930 b, which may improve clearance andcomfort as the penis would be offset from the first and second extensionstruts 3930 a, 3930 b as well.

FIGS. 40A, 40B, 40C, and 40D show a saddle traction device 4000 whichmay be similar to any of the saddle traction devices 3900, 3800, 3700,3600, 3500, 3400, 3200, 3100, 3000 and other described herein. Thesaddle traction device 4000 may comprise a pelvic or groin mount or base4010, a retainer element 4020, and a single extension strut pair 4030extending from one side of the base 4010 and coupled thereto with anadjustable hinge 4040 to couple to the retainer element 4020. Providingonly an extension struts on one side of the base 4010 may provideimproved clearance and catheter access. Having a pair of extensionstruts 4030 may reduce inadvertent rotation of the retainer element4020. The saddle traction device 4000 may further comprise atelescoping, infinitely adjustable tensioning mechanism 4045 coupled tothe extension strut pair 4030 and the retainer element 4040.

FIGS. 41A, 41B, 41C, 41D, and 41E show a saddle traction device 4100which may be similar to any of the saddle traction devices 4000, 3900,3800, 3700, 3600, 3500, 3400, 3200, 3100, 3000 and other describedherein. The saddle traction device 3900 may comprise an open, U-shapedpelvic or groin mount or base 4110, a retainer element 4120, a firstextension strut 4130 a extending from the base 4110 and coupled theretowith a coupling 4140 to couple to the retainer element 4120, a secondextension strut 4130 b extending from the base 4110 and coupled theretowith a coupling 4140 to couple to the retainer element 4120, and across-member 4135 connecting the first and second extension struts 4130a, 4130 b to one another. The base 4110 may comprise a malleable wirewith a soft covering for improved patient comfort, customization, anddevice positioning. The first and second extension struts 4130 a, 4130 bmay be coupled to curved extension portions of the base 4110 such thatthe couplings 4140 are positioned away from the main body of the base4110, allowing additional clearance for the patient's anatomy. Thecouplings 4140 may be rigid to provide structural support for theextension struts 4130 a, 4130 b so that tension applied does notinadvertently deform the saddle traction device 4100. The saddletraction device 4100 may further comprise a telescoping, infinitelyadjustable tensioning mechanism 4145 coupled to the second extensionstrut 4130 b and the retainer element 4140. As shown on FIG. 41E, thesaddle traction device 4100 may further comprise a securement strap orbelt which may be secured to the body of the patient so as to maintainpatient contact when the catheter 2200 is not tensioned and to preventpotential slippage, for example.

FIG. 42 shows an exemplary use of a constant force spring mechanism 4200to apply tension to the catheter 2200 extending from the penis 56. Theconstant force spring 4200 may be attached to a leg LG of the patient,such as with medical tape or a strap, to apply tension toward the feet.The constant force spring mechanism 4200 may be attached near the innerknee of the leg LG, for example. Alternatively, tension may be appliedtoward the head and the constant force spring mechanism 4200 may becoupled with the patient at the neck, chest, or abdomen such as with aneck worn lanyard, torso strap, or adhesive. The constant force springmechanism 4200 may maintain constant tension to the catheter 2200 inspite of any patient movement. The constant force spring mechanism 4200may comprise an enclosure 4210, a spring or constant force spring 4220,and a cord 4230 to couple to the catheter. The spring 4210 may applytension to the cord 4220 to pull the cord back within the enclosure 4210much like a retractable tape measure.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. An apparatus for tensioning a catheter insertedinto a patient, the apparatus comprising: a base to couple to thepatient; a retainer element to releasably couple to the catheter; and atensioning mechanism coupled to the base and the retainer element, thetensioning mechanism to adjust tension to the catheter inserted into thepatient.
 2. The apparatus of claim 1, wherein the catheter comprises anexpandable support and wherein the tensioning mechanism is configured toadjust an amount of tension to the catheter to decrease bleeding withinan enclosed tissue space of the patient when the expandable support hasexpanded.
 3. The apparatus of claim 2, wherein the tensioning mechanismis configured to tension the catheter to apply an amount of pressure totissue with the expandable support.
 4. The apparatus of claim 3, whereinthe amount of pressure is greater than a blood pressure of the patient.5. The apparatus of claim 3, wherein the expandable support comprises aballoon.
 6. The apparatus of claim 1, wherein the tensioning mechanismcomprises a spring.
 7. The apparatus of claim 1, wherein the tensioningmechanism comprises a constant force spring configured to apply asubstantially constant tension to the catheter over a stroke length ofthe catheter.
 8. The apparatus of claim 7, wherein the stroke length ofthe catheter is in a range of about 0.5 cm to about 8 cm.
 9. Theapparatus of claim 1, wherein the retainer element comprises a clamp forclamping one or more of the catheter or a medical tape flag coupled tothe catheter.
 10. The apparatus of claim 1, wherein a position of theretainer element relative to the base is adjustable to adjust an amountof tension to the catheter.
 11. The apparatus of claim 1, wherein thebase comprises an enclosure shaped to receive a penis of the patient.12. The apparatus of claim 1, wherein the base defines an accommodationspace for receiving a penis of the patient.
 13. The apparatus of claim1, wherein the base is configured to be placed over a pelvis or groin.14. The apparatus of claim 1, wherein the base comprises a pelvic orgroin mount contoured to match a shape of the pelvis or groin.
 15. Theapparatus of claim 1, wherein the base has an opening to allow thecatheter to pass from an exterior of the base to within a perimeter ofthe base and within an accommodation space.
 16. The apparatus as inclaim 1, wherein the base is U-shaped.
 17. The apparatus as in claim 1,wherein the base comprises a malleable wire with a soft covering. 18.The apparatus of claim 1, wherein the retainer element is coupled to atleast one extension strut.
 19. The apparatus of claim 18, wherein the atleast one extension strut is coupled to and extends from the base, thebase and the at least one extension strut defining an accommodationspace for one or more of a penis or scrotum to pass therethrough. 20.The apparatus of claim 18, wherein the at least one extension strut iscoupled to the base with a hinge.
 21. The apparatus of claim 20, whereinthe hinge is adjustable.
 22. The apparatus of claim 18, wherein the atleast one extension strut is coupled to the base with a rigid coupling.23. The apparatus of claim 18, wherein the tensioning mechanism iscoupled to the at least one extension strut.
 24. The apparatus of claim18, further comprising a tension measurement element or scale coupled tothe at least one extension strut.
 25. The apparatus of claim 18, whereinthe at least one extension strut comprises a plurality of extensionstruts, the base and the plurality of extension struts defining anaccommodation space.
 26. The apparatus of claim 25, further comprising across-member coupling two or more of the plurality of extension strutsto one another.
 27. The apparatus of claim 26, wherein the retainerelement is positioned on the cross-member.
 28. The apparatus of claim 1,wherein the apparatus is collapsible into a flat package.
 29. Theapparatus of claim 1, further comprising a belt or strap coupled to thebase, the belt or strap configured to be wrapped around and strapped toat least a portion of the patient to maintain a position of the baseover a pelvis or a groin of the patient.
 30. The apparatus of claim 1,wherein the tensioning mechanism comprises an adjustable tensioningmechanism.